Awakn Life Sciences Announces Positive Results from Phase II A/B Ketamine-Assisted Therapy for Treatment of Alcohol Use Disorder Trial

Awakn Life Sciences Announces Positive Results from Phase II A/B Ketamine-Assisted Therapy for Treatment of Alcohol Use Disorder Trial

Primary and Secondary Endpoints Achieved, Including 86% Abstinence Over 6 Months Post Treatment and No Serious Adverse Events

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a biotechnology company developing and delivering psychedelic therapeutics (medicines and therapies) to treat addiction, is delighted to announce ground-breaking positive data from their Phase II AB trial. It was the first controlled trial in the world to investigate Ketamine-Assisted Therapy for the treatment of Alcohol Use Disorder (AUD), the results have been published in the American Journal of Psychiatry. The trial was conducted by University of Exeter (UoE) and led by Professor Celia Morgan, Awakn's Head of Ketamine-Assisted Therapy for Addiction and Professor of Psychopharmacology at UoE. Awakn acquired the intellectual property (IP) to the therapy under license for use in further research, its clinics in Europe, and its partnerships globally.

The positive Phase II trial outcome and Awakn's newly formed partnership with the UK National Healthcare Service (NHS) and UoE, paved the way to progress this trial into Phase III. With the ultimate aim of securing regulatory approval for Ketamine-Assisted Therapy to treat AUD in the UK through the NHS and potentially in other territories.

The double-blind placebo-controlled trial included 96 patients with severe AUD, who were randomised to one of four groups: 1) three ketamine infusions (0.8 mg/kg IV over 40 minutes) plus proprietary manualized therapy (KARE); 2) three saline infusions plus KARE therapy; 3) three ketamine infusions plus alcohol education; and 4) three saline infusions plus alcohol education.

The primary outcomes of the trial were 1) Days abstinent in the 6 months after treatment, 2) Relapse at 6 month follow up. The findings showed that ketamine combined with KARE therapy, resulted in total abstinence in 162 of 180 days in the following 6-month period, achieving an increase in abstinence from around 2% prior to the trial to 86% post trial. The results for relapse at 6 months, showed that the Ketamine plus KARE group's risk of relapse, was 2.7 times less than the placebo plus alcohol education group.

"Alcohol Use Disorder is a pervasive and persistent public health issue, affecting at least 390 million people globally. Treatment rates are low and relapse rates post treatment tend to be high. We urgently need new and more effective treatments," said Prof. Morgan. "We found that controlled, low doses of ketamine combined with manualized psychological therapy can significantly increase post treatment abstinence rates. This is extremely encouraging, as we normally see three out of four people returning to heavy drinking within twelve months of treatment. The data we've collected from this study paves the way for a paradigm shift in how AUD is treated."

The secondary outcomes of the study identified further encouraging results including improved liver function across several different markers, a statistically significant decrease in depression after 3 months and an increase in the ability to experience pleasure.

In addition to the primary and secondary endpoints, Prof. Morgan identified further significant results in the reduction in heavy drinking days. At six months post trial, there was an average of 12 heavy drinking days in the Ketamine plus KARE group, this is a large reduction compared to other trials in this area and it is widely believed the real-world data is far higher than this. Within the KARE group there was also a significant decrease in the risk of mortality, 1 in 8 patients would have died within 12 months without treatment, that number decreased to 1 in 80 following the treatment.

In total, the trial demonstrated that three subanesthetic infusions of ketamine support abstinence from alcohol and that abstinence may be further enhanced when ketamine treatment is combined with therapy. No serious adverse events took place during the trial.

Anthony Tennyson, Awakn's Chief Executive, added, "We are so pleased to see such encouraging results in an area of treatment that has been stagnant for so long, leaving so many people with little or sub-par options available to them. We will continue to support this research and future clinical trials as we push to bring a radical shift in the alcohol addiction treatment industry."

See following link for presentation of KARE results - Awakn Life Sciences - KARE Presentation.

Awakn will hold a conference call to go through the results in further detail.

Conference Call Details:
Date: Wednesday, January 12, 2022
Time: 8:00 a.m. Eastern Time
Toll-free Dial-in Number: 1-877-407-0789
International Dial-in Number: 1-201-689-8562
Conference ID: 13725796

Participant Link: https://viavid.webcasts.com/starthere.jsp?ei=1518205&tp_key=b24ddb9685.

A telephone replay will be available through Wednesday January 26, 2022. To access the replay, please dial 1-844-512-2921 (domestic) or 1-412-317-6671 (international). At the system prompt, please enter the code 13725796 followed by the # sign. You will then be prompted for your name, company, and phone number. Playback will then automatically begin.

About Awakn Life Sciences Corp.

Awakn Life Sciences is a biotechnology company developing and delivering psychedelic therapeutics (medicines and therapies) to better treat addiction. Awakn's team consists of world leading chemists, scientists, psychiatrists, and psychologists who are developing and advancing the next generation of psychedelic drugs, therapies, and enabling technologies to treat addiction. Awakn will deliver these evidence backed psychedelic therapies in clinics in the UK and Europe and through licensing partnerships globally.

www.awaknlifesciences.com | Twitter | LinkedIn | Facebook

Notice Regarding Forward-Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as "forward-looking statements"). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company's future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "continues", "forecasts", "projects", "predicts", "intends", "anticipates", "targets" or "believes", or variations of, or the negatives of, such words and phrases or state that certain actions, events or results "may", "could", "would", "should", "might" or "will" be taken, occur or be achieved, including statements relating to the proposed NEO listing, and the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include: whether conditions to the listing on NEO will be satisfied; the business plans and strategies of the Company, the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company's public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, other than as required by law.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company's and Awakn's securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Investor Enquiries:
KCSA Strategic Communications
Valter Pinto / Tim Regan
Phone: +1 (212) 896-1254
Awakn@KCSA.com

Media Enquiries:
America and Canada: KCSA Strategic Communications
Anne Donohoe
Adonohoe@KCSA.com

Rest of World: ROAD Communications
Paul Jarman / Anna Ramsey
Awakn@roadcommunications.co.uk

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/109595

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Awakn Life Sciences' Phase III Trial to Be Delivered in the UK National Health Service

Awakn Life Sciences' Phase III Trial to Be Delivered in the UK National Health Service

Phase III trial confirmed to cost CA$3.75 million, with a UK Government agency funding 66% of this cost

Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces that its Phase III clinical trial exploring the use of ketamine-assisted therapy for the treatment of severe AUD will be delivered across seven NHS sites in the UK. The trial has also been approved for grant funding for 66% of the costs by the National Institute for Health and Care Research (NIHR), a UK government agency. It is currently forecast the trial will cost approximately CA$3.75 million in total, with Awakn funding approximately CA$1.25 million of that.

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Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces today the signing of a 5-year lease to open Awakn Clinics Trondheim. The new clinic is part of the second stage of Awakn's Nordic expansion plans, following on from last week's announcement of a move to a larger premises for its Oslo clinic.

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 Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces today the signing of a 5-year lease to open a larger Awakn Clinics Oslo. The move to the new Oslo premises is the first stage of Awakn's Nordic expansion plans.

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Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ('Awakn'), a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces it has signed its third Licensing Partnership agreement in North America. The agreement is with Nushama a leading network of ketamine-assisted therapy centers that exist to humanize medicine, together they will bring Awakn's Ketamine-assisted therapy treatment for AUD to Nushama's clinic in New York City (NYC).

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Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ("Awakn"), a revenue-generating biotechnology company researching, developing, and commercializing therapeutics to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), today announces that its wholly-owned subsidiary Awakn Oslo AS ("Awakn Oslo") has entered into a debt financing agreement (the "Loan Agreement") with TD Veen AS (the "Lender"), a family-owned, Norwegian investment company and current shareholder of Awakn.

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Seelos Announces Postponement of its Annual Meeting of Stockholders

Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that its 2024 Annual Meeting of Stockholders (the "Annual Meeting"), which was originally scheduled to be held on September 27, 2024 has been postponed. The Annual Meeting is now scheduled to be held virtually, via live webcast at www.virtualshareholdermeeting.comSEEL2024 on Friday, October 25, 2024 at 8:00 a.m., Eastern Time . The record date for the Annual Meeting August 19, 2024 is unchanged and applies to the postponed Annual Meeting.

(PRNewsfoto/Seelos Therapeutics, Inc.)

The Annual Meeting has been postponed due to an anticipated lack of quorum, and to provide further time to solicit proxies from the Company's stockholders. Seelos' Board of Directors unanimously recommends that you vote FOR the Board of Director nominees and FOR all other proposals identified in the Company's proxy statement for the Annual Meeting. Stockholders who have already cast their votes do not need to take any action, unless they wish to change or revoke their prior proxy or voting instructions, and their votes will be counted at the postponed Annual Meeting. For stockholders who have not yet cast their votes, we urge them to vote their shares now, so they can be tabulated prior to the postponed Annual Meeting.

About Seelos Therapeutics

Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases.

For more information, please visit our website: https://seelostherapeutics.com , the content of which is not incorporated herein by reference.

IMPORTANT ADDITIONAL INFORMATION

Seelos has filed a definitive proxy statement with the Securities and Exchange Commission (the "SEC") on August 20, 2024 . STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) FILED BY SEELOS AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT ANY SOLICITATION. Stockholders may obtain a free copy of the proxy statement and the other relevant materials, and any other documents filed by Seelos with the SEC, at the SEC's web site at http://www.sec.gov or on the "SEC Filings" section of Seelos' website at https://seelostherapeutics.com .

Participants in the Solicitation

Seelos, its directors and executive officers and other members of management and employees will be participants in the solicitation of proxies with respect to a solicitation by Seelos. Information about Seelos' executive officers and directors, including information regarding the direct or indirect interests, by security holdings or otherwise, is available in Seelos' definitive proxy statement for its Annual Meeting, which was filed with the SEC on August 20, 2024 . To the extent holdings by our directors and executive officers of Seelos securities reported in the proxy statement for the Annual Meeting have changed, such changes have been or will be reflected on Statements of Change in Ownership on Forms 3, 4 or 5 filed with the SEC. These documents are or will be available free of charge at the SEC's website at http://www.sec.gov .

Forward-Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements related to Seelos for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements are based on Seelos' current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business and plans described herein include, but are not limited to, the risk of not receiving stockholder approval of any of the proposals to be presented at the Annual Meeting, the risks related to raising capital to fund its development plans and ongoing operations and risks related to Seelos' current stock price, as well as other risk factors and matters set forth in our periodic filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023 , subsequent Quarterly Reports on Form 10-Q, including Seelos' Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 . Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2 nd Floor
New York , NY 10022
(646) 293-2136
anthony.marciano@seelostx.com  
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York , NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/seelos-announces-postponement-of-its-annual-meeting-of-stockholders-302260282.html

SOURCE Seelos Therapeutics, Inc.

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Seelos Therapeutics Announces 1-for-16 Reverse Stock Split

Seelos Therapeutics, Inc. (Nasdaq: SEEL ) ("Seelos" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that its Board of Directors approved a 1-for-16 reverse stock split of its outstanding shares of common stock, to be effective as of 12: 01 a.m. Eastern Time on Friday September 27, 2024.

(PRNewsfoto/Seelos Therapeutics, Inc.)

The Company's common stock, par value $0.001 , will begin trading on a reverse stock split-adjusted basis at the opening of the market on Friday, September 27, 2024. Following the reverse stock split, the Company's common stock will continue to trade on the Nasdaq Capital Market under the symbol "SEEL" with the new CUSIP number, 81577F 406. The reverse stock split is intended for the Company to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market. The reverse stock split was approved by the Company's Board of Directors pursuant to Section 78.207 of the Nevada Revised Statutes and was effectuated by the filing of a Certificate of Change with office of the Nevada Secretary of State.

At the effective time of the reverse split, every sixteen (16) issued and outstanding shares of the Company's common stock will be combined automatically into one (1) share of the Company's common stock without any change in the par value per share. No fractional shares will be issued in connection with the reverse stock split, and any fractional shares resulting from the reverse stock split will be rounded up to the nearest whole share. The reverse stock split will reduce the number of authorized shares of the Company's common stock from 50,000,000 shares to 3,125,000 shares and the ownership percentage of each stockholder will remain unchanged other than as a result of the rounding of fractional shares. In addition, the reverse stock split will apply to the Company's common stock issuable upon the exercise of the Company's outstanding warrants and stock options, with proportionate adjustments to be made to the exercise prices thereof and under the Company's equity incentive plans, as applicable.

The reverse stock split will reduce the number of issued and outstanding shares of the Company's common stock from approximately 9.2 million to approximately 581 thousand.

About Seelos Therapeutics:
Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA), as well as early-stage programs in Huntington's disease, Alzheimer's disease, and Parkinson's disease.

Forward-Looking Statements:
Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the reverse stock split and the timing thereof, the potential impact of the reverse split on the bid price of the Company's common stock, the potential for the Company to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on the Nasdaq Capital Market and the expected number of shares of common stock to be outstanding following the reverse stock split. These statements are based on our current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties involved include those associated with general economic and market conditions, as well as other risk factors and matters set forth in our periodic filings with the SEC, including our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q . Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL )
300 Park Avenue, 2 nd Floor
New York , NY 10022
(646) 293-2136
anthony.marciano@seelostx.com

Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York , NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/seelos-therapeutics-announces-1-for-16-reverse-stock-split-302257773.html

SOURCE Seelos Therapeutics, Inc.

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  • H. C. Wainwright 26th Annual Global Investment Conference: fireside chat at 9:30 am ET on September 10, 2024, and host investor meetings
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A live audio webcast of these events will be accessible from the "Events" page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event.

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COMPASS Pathways to participate in Canaccord Genuity 44th Annual Growth Conference

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A live audio webcast of this event will be accessible from the "Events" page of the Investors section of the Compass website. A replay of this webcast will be accessible for 30 days following such event. For more information, please visit investor section of compasspathways.com.

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Psychedelics Market Update: H1 2024 in Review

The global psychedelics market will likely experience continued growth and interest in the coming years.

According to findings from FactMR, the sector's value is projected to surpass US$603.1 million in 2024, with further growth expected at a CAGR of 7 percent. By 2034, the psychedelics industry is projected to be worth US$1.18 billion.

The field of psychedelics-based therapies has shown significant growth in the past few years as medical companies focus on developing alternative treatments for various mental health conditions, including depression, post-traumatic stress disorder (PTSD), major depressive disorder (MDD), generalized anxiety disorder (GAD), addiction and other ailments.

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