FDA Approves Two Higher Dosage Strengths of Zubsolv
Uppsala, Sweden – December 12, 2014 – Orexo AB announces today that it has received approval from the U.S. Food and Drug Administration (FDA) of two higher dosage strengths of Zubsolv (buprenorphine/naloxone CIII sublingual tablet) for maintenance treatment of opioid dependence. The new dosage strengths are 8.6 mg/2.1 mg and 11.4 mg/2.9 mg buprenorphine/naloxone CIII sublingual tablets. The 8.6 mg/2.1 mg dosage strength is expected to be launched early 2015 and the 11.4 mg/2.9 mg strength later in 2015.
The new dosage strengths complement the existing strengths of 5.7 mg/1.4 mg and 1.4 mg/0.36 mg tablets and enable patients to receive their optimal dose in one tablet. The new strengths are made with the advanced, proprietary sublingual tablet formulation in Zubsolv providing higher bioavailability, a fast dissolve time, small tablet size, and menthol flavor.
“Orexo remains fully committed to advancing the treatment of opioid dependence. During the summer, we received positive data from the largest clinical trials ever conducted in this disease area. Today, we are proud to announce that the FDA has approved two additional dosage strengths of Zubsolv. These higher dosage strengths will allow more patients to get the right dosage in only one tablet and thus reduce the need to combine different dosage strengths. This will improve patient convenience and adherence while reducing their out-of-pocket cost as only one co-pay will be required,” said Nikolaj Sørensen, CEO and President of Orexo AB.
The advanced formulation provided by Zubsolv meets the needs expressed by patients, such as improved taste and fast dissolve time. Meeting patient needs may have the potential to improve patient adherence, thus reducing relapse rates and improving successful patient outcomes. Zubsolv is the only opioid dependence treatment option available in the highest level of child resistant, unit dose, F1 packaging, designed to reduce the chance of unintended pediatric exposure.
About Orexo AB
Orexo is a specialty pharma company with commercial operations in the United States and R&D in Sweden developing improved treatments using proprietary drug delivery. The company is commercializing its proprietary product, Zubsolv® sublingual tablets, for maintenance treatment of opioid dependence, in the United States. The Zubsolv sublingual tablet is a novel formulation of buprenorphine and naloxone using Orexo’s extensive knowledge in sublingual technologies. Orexo has a portfolio of two approved and revenue generating products currently marketed under license in the US, EU and Japan. Orexo AB, with its headquarters in Sweden, is listed on Nasdaq Stockholm Exchange (STO: ORX) and its American Depositary Receipts (ADRs) trade on the OTCQX marketplace in the U.S. under the symbol, “ORXOY”. The largest shareholders are Novo A/S and HealthCap.
Source: Orexo AB
Posted: December 2014
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- FDA Approves Zubsolv for Induction of Buprenorphine Maintenance Therapy in Patients Suffering from Opioid Dependence - August 11, 2015
- FDA Approves Zubsolv for the Maintenance Treatment of Opioid Dependence - July 8, 2013
- Orexo announces that Zubsolv has been accepted for review by the U.S. Food and Drug Administration (FDA) - November 19, 2012
Zubsolv (buprenorphine and naloxone) FDA Approval History
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