FDA Approves Orexo's Unique Low Dosage of Zubsolv®

Orexo (STO:ORX) announced today that it has received approval from the US Food and Drug Administration (FDA) of a new unique low dose, 0.7mg/0.18 mg, tablet of Zubsolv (buprenorphine/naloxone) sublingual tablet (CIII) for the treatment of opioid dependence. The new dosage is expected to be available in US pharmacies in early 2017.
This new introduction extends Orexo’s best-in-class offering of the
broadest dosage ranges of any buprenorphine/naloxone product on the US
market to six individual dosage strengths. By offering the broadest
dosage range, Zubsolv enables physicians and patients the most optimal
dosing flexibility without compromising the child safety packaging and
stability of the product. All Zubsolv dosages are formulated with the
advanced, proprietary sublingual tablet formulation providing high
bioavailability, a fast dissolve time, small tablet size, and menthol
flavor.
The new Zubsolv 0.7mg uniquely provides a fifty percent lower dose than
any other buprenorphine/naloxone product approved in the US. Prior to
Orexo’s development of the 0.7mg dose of Zubsolv, patients requiring a
lower dosage than available, resorted to dividing existing
buprenorphine/naloxone products into smaller pieces. This practice
jeopardizes dosing accuracy, compromises the child-resistant packaging
and also exposes the products to humidity which carries the risk of
altering the drug’s properties. None of the buprenorphine/naloxone
products approved in the US today are FDA-approved to be divided into
smaller doses.
“The approval of the 0.7mg Zubsolv is another significant milestone for
Orexo because it marks the completion of our pharmaceutical development
plan for Zubsolv. The new dosage has been developed in response to
physician requests to be able to tailor dosing as they taper patients
and ultimately provide a lower minimally effective maintenance dose. At
Orexo, we are dedicated to improve the treatment of opioid dependence
and as part of our commitment, we once again invest in the development
of a product explicitly requested by many physicians,” said Nikolaj
Sørensen, CEO and President of Orexo AB.
The advanced formulation provided by Zubsolv is specifically designed to
meet the needs expressed by physicians and patients. Meeting patient
needs may have the potential to improve patient adherence, reduce
relapse rates and improve patient outcomes. Zubsolv is the only opioid
dependence treatment option available in the highest level of
child-resistant, unit dose, F1 packaging which is designed to reduce the
chance of unintended pediatric exposure.
About Orexo
Orexo is a specialty pharmaceutical company commercializing its
proprietary product Zubsolv® for treatment of opioid dependence in the
US. Zubsolv is an advanced formulation of buprenorphine and naloxone
using Orexo’s unique knowledge and expertise in sublingual drug
delivery. R&D is focusing on reformulation of known substances to new
improved products that meet great unmet medical needs by using its
patented proprietary technologies. Orexo’s share is listed on Nasdaq
Stockholm Exchange Mid Cap (STO:ORX) and is available as ADRs on OTCQX
(ORXOY) in the US. Orexo’s global headquarters and R&D are based in
Uppsala, Sweden.
For more information about Orexo, please visit www.orexo.com
or follow us on Twitter or LinkedIn. For further information about
Zubsolv in the US, please visit www.zubsolv.com.
This information is information that Orexo AB (publ.) is obliged to make
public pursuant to the EU Market Abuse Regulation. The information was
submitted for publication, through the agency of the contact person set
out above, at 8.00am CET on October 6, 2016
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