Industry Briefs

FDA Panel Gives Nod to Approval of Anti-Opioid Implant

The Psychopharmacologic Drugs Advisory Committee of the Food and Drug Administration (FDA) last week voted 12-5 in favor of approving Probuphine. It is the first long-acting, subdermal buprenorphine implant for the management of opioid addiction, according to a press release by Titan Pharmaceuticals Inc., the manufacturer of the product.

In trials, buprenorphine implants resulted in significantly less opioid use compared with placebo implants over 24 weeks. The implants were also found to be no less effective than sublingual buprenorphine/naloxone tablets.

The FDA is scheduled to make a formal decision on the product by February 27.

Psychotropic Drugs Approved In 2015 With Big Expectations

Earlier this month, FierceBiotechreleased a list of drugs approved by the FDA in 2015 that the media outlet predicts will become blockbuster drugs within the next few years based on peak sales estimates. Three psychotropic drugs made the cut:

• Rexulti (brexpiprazole): an add-on therapy for depression and schizophrenia (peak sales estimate $1.4 billion by 2020)

• Vraylar (cariprazine): medication treats schizophrenia and bipolar disorders in adults (peak sales estimate $200 to $300 million/year)

• Aristada (aripiprazole lauroxil): long-acting injectable to treat schizophrenia (peak sales estimate $550M by 2020) ■