Anti-Opioid Approved for New Indication

The FDA has approved Orexo's sublingual buprenorphine/naloxone (Zubsolv) for the induction of buprenorphine maintenance therapy in patients with opioid dependence.

The FDA has approved Orexo’s sublingual buprenorphine/naloxone (Zubsolv), a partial opioid agonist, for the induction of buprenorphine maintenance therapy in patients with opioid dependence.

The drug was previously approved for the maintenance treatment of opioid dependence. With this latest nod, patients can now be transitioned to Zubsolv directly from the opioid on which they are dependent.

The FDA based its approval on data from 2 phase 3 studies in which more than 90% of patients treated with Zubsolv remained on treatment after 3 days. The researchers observed no significant clinical differences between Zubsolv and generic buprenorphine.

“This regulatory milestone supports Zubsolv as an effective induction treatment for patients taking their first step on the pathway to recovery from opioid dependence,” said Michael Sumner, Chief Medical Officer at Orexo. “We know more than 40% of [Drug Treatment Act] 2000 waivered physicians who are less active treating patients cite initiation of treatment as the greatest challenge. With the induction indication, Orexo can take an active role to educate the waivered, but not active, prescribers in initiation of treatment and improve access to treatment for patient suffering from opioid dependence.”

In June 2015, the FDA approved a 2.9-mg/0.71-mg dosage strength of Zubsolv, while an 8.6-mg/2.1-mg dosage strength was launched in the United States in March. The drug is also currently available in 5.7-mg/1.4-mg and 1.4-mg/0.36-mg strengths, with an 11.4 mg/2.9 mg strength set to launch later this year.

The most commonly observed adverse events associated with the use of sublingual buprenorphine/naloxone tablets during clinical trials include headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.