The Food and Drug Administration is convening a panel of experts Thursday to review a new drug to combat treatment-resistant depression from Alkermes (ALKS). The drug, ALKS 5461, is seen as the key to future earnings growth for the company — but it is not without controversy.
It’s likely to be a big day, featuring debate over the opioid-based treatment, messy efficacy data, and a novel clinical trial design that has never before been used to support a drug approval. After chewing over all the data, the experts on the panel will vote on a recommendation to approve ALKS 5461, or not.
