Positive preliminary results in phase 2 study of oral treatment for insomnia in AUD

Imbrium Therapeutics LP, a subsidiary of Purdue Pharma LP, announced positive preliminary results from a phase 2 study of an investigational oral treatment for patients with insomnia during recovery from an alcohol use disorder.

The data were presented at the 33rd Annual Meeting and Scientific Symposium of the American Academy of Addiction Psychiatry.

According to a company release, sunobinop (IMB-115/V117957, Imbrium) is an internally discovered compound whose mechanism of action is designed to bind to and activate the nociceptin/orphanin-FQ peptide receptor (NOP), a protein that is widely expressed in the central and peripheral nervous system and is involved in a range of biological functions including modulation of anxiety, response to stress and substance abuse.

The randomized, double-blind, multicenter, placebo-controlled, parallel-group clinical study enrolled 114 people assigned at a 1:1:1 ratio to receive sunobinop in either 1 mg or 2 mg doses or placebo every night at bedtime for 21 days.

The primary endpoint was change from baseline on wakefulness after sleep onset (WASO; or the time spent awake after falling asleep), as measured by two consecutive nights of overnight polysomnography assessed on nights 1 and 2 as well as nights 20 and 21 of dosing, the company said in the release.

Results showed that both doses of sunobinop met the primary endpoint, with “significant and clinically meaningful” reductions in WASO, compared with placebo, maintained across the 3 weeks of dosing in the study.

In addition, per the release, impact on sleep was demonstrated for several secondary endpoints as measured by polysomnography while effects on subjective sleep measures collected did not reach statistical significance.

“Our research program with sunobinop, and specifically results from this phase 2 clinical study, underscore our commitment to advancing medicines that may benefit patients who are in recovery,” Julie Ducharme, BPharm, MSC, PhD, vice president and chief scientific officer at Purdue Pharma LP stated in the release.

According to the release, sunobinop was well-tolerated across both doses with no serious adverse events reported. All treatment-emergent adverse events were mild or moderate, with the most common being somnolence (or drowsiness), reported in 5% of the sunobinop 1 mg group and 26% of the sunobinop 2 mg group. Baseline alcohol craving scores as assessed via the Penn Alcohol Craving Scale were low with no increase in craving observed in any treatment group.

“Currently, there are no FDA-approved products specifically indicated for insomnia during recovery from AUD,” Nelson Sessler, PharmD, lead author on the study, said in the release. “We appreciate the opportunity to present our findings at AAAP.”