Adamis Submits NDA for New Product

Adamis Pharmaceuticals (NASDAQ:ADMP) announced it submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) on Monday (December 31) after market close.

The application was for Adamis’ naloxone pre-filled single dose syringe (PFS) product candidate, as a treatment for opioid overdose. Adamis has developed this candidate, currently APC-6000, using the patent Symject syringe drug delivery platform. The news of this NDA meets the company’s predicted date to submit it before 2018’s year end.

The potential for this product has a growing demand to aid the opioids epidemic in the US. According to the National Institute on Drug Abuse there were 72,000 drug overdose deaths estimated in 2017. Drug overdoses are now the leading cause of death for Americans under the age of 50.

“There is a need for additional treatment options to combat the [opioid] crisis,” Dr. Dennis Carlo, president and CEO of Adamis, said in the press release. He added this is one of the two NDAs the company has with the FDA.

“We are continuing to assess additional compounds for possible use with our injection platform,” he said, adding he believes the company will have a “solid” growth in 2019.

According to Adamis’ company presentation, this naloxone product has a total addressable market of US$335 million. This product is for a novel high dose of naloxone, of 2 mg/ml.

The other drug the company is preparing an NDA for is Tadalafil, from a sublingual tablet for erectile dysfunction. Other drugs the company has in development are for asthma and chronic obstructive pulmonary disease (COPD); which being developed in a dry powder inhaler platform or a metered dose inhaler.

Adamis is launching its first product Symjepi, which is expected this quarter. In September, Adamis received its second approval for Symjepi as a lower dose for version. The product is approved for the emergency treatment of allergic reactions, including anaphylaxis, designed for patients weighing 66 pounds or more. The lower dose version is intended to potentially treat patients weighing between 33-66 pounds.

Naloxone is a commonly used drug to treat narcotic overdoses. It works as an opioid antagonist and blocks or reverses the effects of the opioid. This includes slowed breath, loss of consciousness and drowsiness which can cause death.

Investor Takeaway

Over Wednesday’s trading period, Adamis’ share price had a small increase of 6.22 percent to US$2.39 as of market close.

According to TipRanks, Elliot Wilbur, analyst with Raymond James reiterated a “Buy” position for the company on Wednesday.

Investors can check back on Adamis’ news about its other upcoming NDA, product launch and other news to its pipeline. Another upcoming milestone is the commencement of a Phase 3 study for the metered dose inhaler for asthma and COPD.

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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.