Alkermes’ (NASDAQ:ALKS) ALKS-5461 is likely to require an additional Phase III major depressive disorder (MDD) trial based on previous mixed clinical results before regulators will approve the therapy, experts said.
The drug has been tested in two negative and one positive Phase III trials. Experts noted that as the drug saw high placebo responses in its negative FORWARD-3 and FORWARD-4 Phase III trials, there may be specific ways to design an additional pivotal trial, such as sequential design or better patient selection, to limit this. The Phase III FORWARD-5 study was positive, the company has announced, without disclosing further details.
One analyst report notes the drug is approvable with one positive Phase III trial whilst noting that it can reach USD 1bn of sales within five years of launch.
On 20 October, Alkermes’ CMO said in a press release that based on the previous data, the company would move forward rapidly to meet with the FDA to determine the appropriate next steps toward a regulatory submission for ALKS- 5461. The company has not commented on an EMA submission. Alkermes did not respond to a request for comment.