FDA Rejects Alkermes Depression Drug, Asks for More Clinical Data

Xconomy Boston — 

The FDA has rejected a depression drug from Alkermes, unpersuaded that the company’s experimental treatment actually works.

Alkermes said Friday afternoon that the FDA’s letter asked the company for additional clinical data “to provide substantial evidence of effectiveness” for the drug, ALKS 5461. The company, which is based in Dublin, Ireland, and maintains a large presence in Waltham, MA, said it plans to meet with the FDA to discuss the regulator’s concerns.

Shares of Alkermes (NASDAQ: ALKS) dipped nearly 5 percent to $31.50 in after-hours trading.

The Alkermes drug, ALKS 5461, was developed as a treatment for patients whose major depressive disorder has not responded to other antidepressant drugs. The once-daily pill combines buprenorphine, an opioid stimulator, with another compound intended to block the addictive properties of the opioid. The drug is intended to provide an alternative to selective serotonin reuptake inhibitors (SSRIs), a class of commonly prescribed depression drugs.

Alkermes tested its drug with a clinical trial design consisting of two stages—one Phase 2 study and three Phase 3 tests. But only one of the Phase 3 trials hit its main goal, and in that study, the company measured patients’ depression symptoms over multiple weeks and averaged them. Last April, the FDA said it could not review the Alkermes drug without more clinical data. Weeks later, the FDA changed its mind after the company said it clarified aspects of its drug application.

But the clinical trial design that Alkermes used continued to raise questions. It’s a design that the FDA hasn’t reviewed before—a point that came up in the agency’s staff review of the drug application. An independent advisory panel to the FDA also expressed skepticism about the clinical data that Alkermes submitted. In November, that panel voted overwhelmingly against recommending approval of the drug.

It might be the end of the road for ALKS 5461, according to SVB Leerink analyst Marc Goodman. In a research note, he wrote that another clinical trial would be long and expensive, and the FDA has already voiced its concerns about the company’s clinical trial design. He added that the opioid crisis raises more hurdles for the approval and commercial success of drug that has an opioid component. “Even though the FDA requested additional clinical data on the product, we believe that it would be a major uphill battle for Alkermes to continue the program,” Goodman wrote.

The FDA’s rejection of the Alkermes depression drug caps a tough week for neuroscience drugs. A Parkinson’s disease drug from Sunovion Pharmaceuticals also failed to pass muster with the FDA, though the company said that the regulator did not ask for new clinical trials. That decision came after an announcement by Roche and partner AC Immune (NASDAQ: ACIU) that they would stop work on an Alzheimer’s disease drug after an interim analysis showed the compound was likely to fail late-stage testing. Alkermes said that after it meets with the FDA, the company will assess whether its drug has a viable path forward.

Photo by Flickr user Joel Kramer via a Creative Commons license