Med Check

Phase 3 Results for Insomnia Agent Suggest Efficacy

People with insomnia who take the investigational agent lemborexant may find themselves falling asleep faster and sleeping more soundly, according to data presented in February by Eisai Co. Ltd. and Purdue Pharma L.P.

As part of the phase 3 trial, 949 adults with insomnia disorder were randomized to lemborexant (5 mg or 10 mg) or placebo for six months. Participants were asked to keep electronic sleep diaries throughout the trial.

At the end of six months, patients who took lemborexant 5 mg reported falling asleep roughly 22 minutes faster on average than before, and those who took lemborexant 10 mg reported falling asleep roughly 28 minutes faster on average than before. Those who took placebo reported falling asleep roughly 12 minutes faster on average. Patients assigned to lemborexant also reported that they felt they had slept better and had longer periods of sleep compared with those in the placebo group.

Lemborexant is thought to work by blunting wakefulness without impeding the ability to awaken in response to external stimuli.

FDA Nixes Alkermes’ Combo Depression Drug

In February the Food and Drug Administration (FDA) rejected Alkermes’ new drug application for ALKS 5461, a combination pill containing samidorphan and buprenorphine intended for adjunctive treatment for major depressive disorder. According to a release issued by Alkermes, the FDA has requested additional data to provide substantial evidence of the drug’s effectiveness.

The decision by the FDA to reject ALKS 5461 came months after an advisory panel recommended against approval of the medication. In an FDA briefing document, the Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee described concerns over whether chronic exposure to the drug would increase the risk of opioid dependence, misuse, and abuse and whether it would be possible for individuals who wish to misuse the buprenorphine component to chemically separate it from the samidorphan in the pills.

The company said it plans to meet with the FDA to discuss potential next steps for ALKS 5461.

Roche Drops Two Phase 3 Trials of Alzheimer’s Therapy

At the end of January, Roche announced the discontinuation of two phase 3 trials of crenezumab—an investigational monoclonal antibody designed to target neurotoxic oligomers, a form of beta-amyloid.

The company decided to end the CREAD 1 and CREAD 2 trials, which were studying the agent in people with early sporadic Alzheimer’s disease, after an interim analysis by the Independent Data Monitoring Committee indicated that the agent was unlikely to meet its primary endpoint of change from baseline in the Clinical Dementia Rating Sum of Boxes score. The CREAD 1 trial began in 2016, and the CREAD 2 began in mid-2017.

Crenezumab will remain under study as part of the Alzheimer’s Prevention Initiative (API) trial, a five-year study in collaboration with the Banner Institute and funded by the National Institute on Aging. Participants in the API trial are cognitively healthy but have an increased risk of developing familial Alzheimer’s disease because they have a genetic mutation.

PPD Medication Shows Promise in Phase 3 Trial

The investigational oral medication SAGE-217 may reduce depressive symptoms in women with postpartum depression (PPD) within two weeks, suggest the results of a phase 3 trial. Sage Therapeutics, manufacturer of SAGE-217, announced the findings in January.

In the ROBIN Study, women with severe PPD (Hamilton Rating Scale for Depression-17 [HAMD-17] ≥26) who received 30 mg of SAGE-217 for two weeks experienced a statistically significant improvement of 17.8 points in HAMD-17 score, compared with an improvement of 13.6 points for placebo. This effect was maintained through the four-week follow-up.

Among those who took the medication, 45 percent achieved remission at two weeks, compared with 23 percent of those in the placebo group. At the end of the four-week follow-up, 53 percent of patients who took SAGE-217 achieved remission compared with 30 percent of patients who took placebo.

FDA Clears Digital Therapeutic for People With PTSD

The FDA in December cleared Palo Alto Health Sciences Inc.’s digital therapeutic Freespira to treat patients with posttraumatic stress disorder (PTSD).

Previously approved for treating panic attacks, Freespira uses a sensor to measure breathing rate and exhaled carbon dioxide levels and a handheld tablet to provide instant feedback to users with the aim of training them on how to change their breathing patterns. Treatment for PTSD entails two 17-minute sessions a day for four weeks and is authorized and completed under the supervision of a licensed health care provider.

In a study of patients with PTSD at the Veterans Administration Paolo Alto Health Care System, researchers found that at two and six months after treatment, 93 percent and 91 percent of patients who used Freespira achieved at least a six-point reduction in their Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score, respectively. At six months, 86 percent of users had a 13-point reduction in CAPS-5 score, and 50 percent no longer met the diagnostic criteria for PTSD. ■