Med Check

In September, the Food and Drug Administration (FDA) approved Cassipa, a sublingual buprenorphine/naloxone film, for the maintenance treatment of opioid use disorder (OUD). Cassipa, manufactured by Teva Pharmaceuticals, provides 16 mg of buprenorphine and 4 mg of naloxone per film, which is a higher dose than currently available with brand-name or generic buprenorphine/naloxone sublingual formulations.

The FDA noted in its approval that Cassipa is to be used only as part of a complete medication-assisted treatment plan that includes counseling and psychosocial support. In addition, Cassipa should be used only after a patient has been stabilized up to a dose of 16 mg of buprenorphine using other approved products. As with currently marketed buprenorphine/naloxone films, Cassipa may be prescribed only by Drug Addiction Treatment Act (DATA)–certified prescribers.

Cassipa was approved through the FDA’s abbreviated 505(b)(2) pathway, which allows manufacturers to use existing drug safety data as part of the approval process. Teva provided evidence that Cassipa has a similar safety profile to Suboxone, Invidior’s FDA-approved buprenorphine/naloxone film available in doses ranging from 2 mg/0.5 mg to 12 mg/3 mg. Buprenorphine/naloxone sublingual films can cause numbness or a burning feeling in the mouth, inflammation of the mucous membrane, headache, nausea, vomiting, excess sweating, constipation, insomnia, pain, and peripheral edema.

In August, the FDA rejected Sunovion’s New Drug Application (NDA) for dasotraline for treatment of attention-deficit/hyperactivity disorder (ADHD).

According to the agency, additional clinical data are needed to further evaluate the efficacy and tolerability of dasotraline—a dopamine and norepinephrine reuptake inhibitor with an extended half-life that supports the potential for once-daily dosing.

“While we are disappointed with the FDA’s decision, we remain confident in the future of dasotraline,” said Antony Loebel, M.D., executive vice president and chief medical officer at Sunovion in the company’s press release. “We plan to discuss next steps for the dasotraline ADHD program with the FDA as soon as possible.”

To date, dasotraline has been evaluated in approximately 2,500 children and adults with ADHD in multiple placebo-controlled studies, as well as two long-term safety studies, according to the company.

Dasotraline is also being tested for the treatment of moderate to severe binge eating disorder in adults.

The FDA has cleared a three-minute treatment protocol for a repetitive transcranial magnetic stimulation (rTMS) system by Magventure, the company announced in August. The FDA first cleared Magventure’s rTMS therapy system in 2015 for adults with treatment-resistant depression. Previously, each treatment session using this rTMS system took between 20 minutes and 40 minutes.

The new treatment protocol, which is known as theta burst stimulation (TBS), was cleared on the strength of a randomized clinical study comparing outcomes in adults with treatment-resistant depression who received two to four weeks of TBS with those who received conventional rTMS.

At the end of the study, reductions in depressive symptoms (using the 17-item Hamilton Rating Scale for Depression) were similar between the groups: a 7.8-point drop for TMS and 7.9-point drop for TBS. While self-rated intensity of pain associated with treatment was greater in the TBS group than in the 10 Hz TMS group, dropout rates were similar in both groups.

NeuroRx has announced some positive data related to mood and suicidal ideation from its phase 2 trial of NRX-101 in patients with severe bipolar disorder. NRX-101 is a combination of lurasidone and the NMDA antagonist D-cycloserine.

The STABIL-B study enrolled 20 patients with bipolar disorder who presented for emergency care with acute suicidal ideation. The patients were randomized to receive ketamine followed by oral NRX-101 or lurasidone.

Though this study was not powered for efficacy, the data showed positive trends in relation to the remission of depressive and suicidal symptoms as well as prevention of relapse. The study also demonstrated that NRX-101 was well tolerated; there were no serious adverse events, and no patient had to be taken off NRX-101 due to side effects.

NeuroRx has now initiated a phase 2b/3 pivotal study for the same indication under a Special Protocol Assessment (SPA), in which the drug manufacturer and FDA agree on a clinical trial protocol ahead of time. This allows companies to quickly initiate larger trials once small studies show positive findings. ■