An Alkermes depression drug has stalled at the FDA after the regulator concluded that the company must provide more information, including additional data from new clinical trials.
Alkermes (NASDAQ: ALKS) said Monday that it has received a “refusal to file” letter for ALKS 5461, the company’s drug for treating major depressive disorder. Such letters let a company know that the FDA has found deficiencies in a new drug application. Alkermes, which is based in Dublin, Ireland and also has operations in Waltham, MA, said the FDA concluded that the company provided “insufficient evidence of overall effectiveness,” and more clinical trials are needed before the application can be resubmitted. Alkermes also said that the FDA asked the company to conduct a study to assess the drug’s bioavailability—how much of the drug is circulating in the body and able to have an active effect.
“Alkermes strongly disagrees with the FDA’s conclusions and plans to appeal the FDA’s decision,” the company said in a prepared statement.
Alkermes’s ALKS 5461 is a once-a-day pill developed to treat patients who don’t respond to selective serotonin reuptake inhibitors (SSRIs) a class of drugs commonly prescribed for depression. The Alkermes drug was developed to create a balance among the opioid receptors in the brain. The drug combines an opioid stimulator (buprenorphine) and an inhibitor, which Alkermes has said is meant to allow its drug to maintain its anti-depressive effect while blocking the addictive properties of an opioid.
In 2016, results from a Phase 3 study showed that the Alkermes drug failed to meet its main goals of reducing symptoms of depression. But the company reported more encouraging data later that year after changing its statistical analysis of the trial. At that time, Alkermes said it had enough data to support an application for FDA approval of the drug.
On Monday, Alkermes said it plans to request a meeting with the FDA to get a better understanding of what it needs to do in order to resubmit its drug application.