Med Check: Psilocybin for OCD, Nuplazid Vote, and More

The U.S. Food and Drug Administration (FDA) has given fast track status to AD109, an investigational oral medication for the treatment of obstructive sleep apnea, Apnimed announced in June. The FDA fast track is a process designed to facilitate the development of drugs that treat serious conditions and fill an unmet medical need and to expedite their review.

AD109 contains the selective norepinephrine reuptake inhibitor atomoxetine and the selective antimuscarinic aroxybutynin. AD109 targets key neurological pathways that cause upper airway obstruction during sleep by activating the upper airway dilator muscles and maintaining an open airway during sleep.

In a phase 2 trial of 32 adults with mild to moderate obstructive sleep apnea, patients who took AD109 experienced less hypoxic burden compared with patients who took placebo. Hypoxic burden is a measure of the total amount of respiratory event-related hypoxemia, or low blood oxygen during sleep. Patients who took AD109 also had fewer episodes of apnea and hypopnea per hour of sleep compared with patients who took placebo.

 

The FDA has accepted Ceruvia Lifesciences’ Investigational New Drug application for a phase 2 clinical trial to determine the efficacy and safety of SYNP-101 (synthetic psilocybin) for the treatment of obsessive-compulsive disorder (OCD), the company announced in June.

In the trial, 105 patients with OCD will receive 25 mg of SYNP-101 or the active placebo niacin. The primary endpoint of the trial will be to determine the reduction in OCD symptoms for up to 12 weeks after a single dose of SYNP-101. Researchers will determine the drug’s efficacy using the Yale-Brown Obsessive Compulsive Scale.

 

In June the FDA Psychopharmacologic Drugs Advisory Committee voted 9 to 3 that available evidence does not support Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis, Acadia Pharmaceuticals announced. The drug is currently approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

The company submitted the application in 2020 after the phase 3 HARMONY trial suggested that pimavanserin may reduce the risk of psychosis relapse in patients with common subtypes of dementia including Alzheimer’s disease, dementia with Lewy bodies, Parkinson’s disease dementia, vascular dementia, and frontotemporal dementia spectrum disorders. However, the advisory committee noted that study’s conclusions about the primary endpoint—the effect of pimavanserin on time to relapse of psychosis—appeared to spring mostly from the results in patients with psychosis from Parkinson’s disease, not Alzheimer’s disease.

The advisory committee also questioned the findings of a phase 2 trial of pimavanserin in patients with Alzheimer’s disease. The committee said the trial was not well controlled and that more than half of the patients in both the treatment and placebo groups deviated from the trial’s protocol.

The FDA does not have to act on the advisory committee’s recommendations, although the agency will consider them in making a decision on whether to approve pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis. The target date for FDA action is August 4, 2022.

 

In June AbbVie announced that it has submitted a supplemental New Drug Application to the FDA to expand the labeling for Qulipta (atogepant) to include prevention of chronic migraine in adults. The drug is currently approved for the preventive treatment of episodic, not chronic, migraine in adults.

The submission includes data from the phase 3 PROGRESS trial in patients with chronic migraine, which found that adults with chronic migraine who took the drug experienced fewer monthly migraine days over the course of 12 weeks compared with those who took placebo.

In the trial, more than 750 patients with at least a one-year history of chronic migraine were randomized to receive 60 mg of atogepant once a day, 30 mg of atogepant twice a day, or placebo for 12 weeks. All patients had at least 15 headache days with at least eight migraine days in the 28 days before randomization. The trial consisted of two analyses based on regulatory agency feedback in the United States and European Union.

The U.S. analysis revealed that patients in the 60 mg and 30 mg atogepant arms experienced a decrease of 6.88 and 7.46 monthly migraine days, respectively, compared with patients in the placebo arm, who experienced a decrease of 5.05 monthly migraine days. The European Union analysis revealed that patients in the 60 mg and 30 mg atogepant arms experienced a decrease of 6.75 and 7.33 monthly migraine days, respectively, compared with patients in the placebo arm, who experienced a decrease of 5.09 monthly migraine days.

 

Zuranolone may reduce symptoms of postpartum depression, the phase 3 SKYLARK Study has found. The results of the study were announced by Sage Therapeutics and Biogen in June.

In the trial, 195 women with postpartum depression were randomized to take either 50 mg of zuranolone or placebo once per night for 14 days. On Day 15, scores on the 17-item Hamilton Rating Scale for Depression dropped a mean of 15.6 points among women who took zuranolone compared with a mean decrease in score of 11.6 points among women who took placebo. Women who took zuranolone also experienced greater improvement in their depressive symptoms as measured by the Clinical Global Depression Severity Scale than those who took placebo. ■