Industry Briefs

Experimental Insomnia Medication Shows Promise in Phase 2 Trial

Idorsia’s experimental insomnia candidate ACT-541468 has met its primary endpoints in a pair of phase 2 trials, setting the stage for a phase 3 study of this dual orexin receptor antagonist (DORA).

For the first study, researchers randomly assigned 360 adults aged 18 to 64 to one of three doses of ACT-541468 (5 mg/d, 10 mg/d, or 25 mg/d), zolpidem (10 mg/d), or placebo for four weeks. Participants taking ACT-541468 showed a significant dose-dependent decrease in wake time after sleep onset over zolpidem, with improvements being evident within two days. Participants in the ACT-541468 group also appeared to fall asleep faster. The treatment was generally well tolerated and there were no reports of serious adverse events.

In a separate study of 58 older patients aged 65 and older, ACT-541468 showed similar safety and efficacy.

“The positive results of the phase 2 program demonstrate that our DORA can deliver on the potential its mechanism of action offers in insomnia,” Guy Braunstein, M.D., the head of Global Clinical Development at Idorsia, said in a press release.

Generic Paroxetine Lots Recalled Due to Stability Issues

Lupin Pharmaceuticals Inc. has voluntarily recalled 12,480 bottles of generic paroxetine extended-release tablets (12.5 mg) from the U.S. market.

As detailed in a recent FDA Enforcement Report this Class III recall stems from failed dissolution specifications of these capsules in a three-month stability test. A Class III recall is initiated in a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

The recalled paroxetine involves lots H605710, H605711, and H605712 (expiration: November 2018); and lots H702202 and H702255 (expiration: March 2019). ■