Med Check

The Food and Drug Administration (FDA) has approved Abilify Maintena—a once-monthly injectable formulation of the antipsychotic aripiprazole—for the maintenance of bipolar I disorder in adults. Abilify is manufactured by Otsuka and Lundbeck.

This approval was based on a large, year-long phase 3 study in adults aged 18 to 65 with bipolar disorder I. Abilify Maintena significantly delayed time to recurrence of any mood episode during the study compared with placebo. The trial also found significant differences between treatment groups in delaying time to recurrence of both manic and mixed episodes but no substantial difference in depressive mood episodes.

“Abilify Maintena provides health care professionals a new treatment option for their patients who have established tolerability with oral aripiprazole,” said Joseph Calabrese, M.D., director of the Mood Disorders Program at University Hospitals Cleveland Medical Center, in a press release from Otsuka. He added that concomitant oral antipsychotic medication must be administered for 14 days after the first injection.

Nektar Therapeutics announced positive results from a Human Abuse Potential (HAP) study of its opioid analgesic NKTR-181—a mu-opioid agonist designed to provide potent pain relief without the euphoria that can lead to opioid abuse and addiction.

The NKTR-181 HAP study evaluated the relative oral abuse potential of NKTR-181 at its maximum analgesic or therapeutic dose (400 mg) and at supratherapeutic doses (600 mg and 1,200 mg).

The study found that NKTR-181 had significantly lower peak and average ratings of drug liking at 400 mg as well as the supratherapeutic dose of 600 mg compared with common therapeutic doses of oxycodone (40 mg or 60 mg). NKTR-181 1,200 mg had comparable drug liking to 60 mg of oxycodone.

Nektar had previously completed a phase 3 efficacy trial in March 2017 demonstrating positive results in 610 opioid-naïve patients with moderate to severe chronic low back pain. That study also demonstrated a favorable safety and tolerability profile.

The FDA has granted NKTR-181 a Fast Track designation for the treatment of moderate to severe chronic pain.

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.

The genetic testing company 23andMe is partnering with the Milken Institute and Lundbeck on a new genetic study of major depressive disorder (MDD) and bipolar disorder (BD).

This first-of-its-kind study aims to enroll 25,000 participants (15,000 with MDD and 10,000 with BD) to learn how genes and environment affect brain processes in people with these two conditions. The study will acquire data through genotyping, cognitive assessments, and participant survey responses.

The study is open to individuals in the United States aged 18 to 50 who have a diagnosis of MDD or BD and been prescribed medication to treat their condition; they must also have a computer with Internet access. More details can be accessed here. ■