Med Check

FDA Approves First Generic Versions of Suboxone Sublingual Film

In June, the Food and Drug Administration (FDA) approved the first generic versions of sublingual Suboxone (buprenorphine and naloxone) for the treatment of opioid dependence. Mylan Technologies Inc. and Dr. Reddy’s Laboratories SA received approval to market buprenorphine and naloxone sublingual films in multiple strengths.

As with brand name Suboxone, these new generic formulations may only be prescribed by Drug Addiction Treatment Act–certified prescribers.

These approvals represent one part of the FDA’s ongoing strategy to increase access to and encourage wider use of medication-assisted treatment for opioid use disorders, the agency noted in a statement announcing the approval of the sublingual Suboxone generic.

FDA Approves Novel Preventive Treatment for Migraine

The FDA in May approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The medication is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide—a molecule that is involved in migraine attacks.

The approval of Aimovig—which is self-administered once monthly via autoinjector—was based in part on the results of three studies. One study, which included 955 patients with a history of episodic migraine, compared Aimovig with placebo. Over the course of six months, Aimovig-treated patients experienced, on average, one to two fewer monthly migraine days than those on placebo. A second study of 577 patients with a history of episodic migraine found Aimovig-treated patients experienced, on average, one fewer migraine day per month than those taking placebo. A third study, which compared outcomes in 667 patients with a history of chronic migraine, found that over the course of three months, patients treated with Aimovig experienced, on average, 2.5 fewer monthly migraine days than those receiving placebo.

Hospira Recalling Two Lots of Naloxone Injections

Hospira Inc., a division of Pfizer, is voluntarily recalling two lots of its naloxone hydrochloride injectables due to the potential presence of embedded and/or loose particulate matter on the syringe plunger.

If patients are injected with these particulates, there is a low chance of experiencing adverse events including local skin irritation, vein inflammation, injection-site granulomas, pulmonary embolism or infarction, and toxicity. As of Hospira’s announcement in early June, though, the company had not received any reports of adverse events associated with these lots.

The affected lot numbers are 72680LL (expiration December 1, 2018) and 76510LL (expiration April 1, 2019). Both lots contain single-use naloxone injections at 0.4 mg/mL (1 mL naloxone in 2.5 mL solution) and were distributed to wholesalers and hospitals nationwide between February 2017 and February 2018.

Sandoz Strikes Deal to Market Pear’s Digital Therapeutics

Sandoz, a division of Novartis, has entered a deal with Pear Therapeutics to commercialize Pear’s two lead products, the digital therapeutics reSET and reSET-O.

The FDA cleared reSET in September 2017 for the treatment of patients with non-opioid substance use disorders. The agency granted reSET-O, which is specifically targeted for opioid use disorder, expedited status in October 2017; the digital therapeutic is currently under FDA review.

According to Pear Therapeutics, Sandoz will assume responsibility for the global commercial launch of reSET and reSET-O, including ensuring market access, providing a sales force, and collecting reimbursements. Pear will continue to develop both digital therapeutics and support patient services through its digital hub. In addition to an upfront payment, the deal includes research and development funding, commercial milestones, and a profit split on net sales of both therapeutics.

FDA Advisory Group Gives Insys Buprenorphine Spray Thumbs Down

Participants in a joint meeting of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and its Drug Safety and Risk Management Advisory Committee in May voted 18-1 not to recommend the approval of a new immediate-release sublingual buprenorphine spray for the treatment for moderate-to-severe acute pain.

The spray, made by Insys Development, is meant to manage acute pain when the use of an opioid analgesic is appropriate. Documents reviewed by the advisory committees suggested that the shortest median time for the medication to begin working at the highest tolerated dose was 92 minutes. Some committee members suggested such a delay in pain relief could lead patients to take another painkiller in the interim. Committee members also cited poor efficacy of the medication.

Trintellix Label Adds Data on Cognitive Improvement

The FDA in May approved an update to the label of vortioxetine (Trintellix) to include data showing the medication can lead to some cognitive improvements. According to H. Lundbeck A/S, Trintellix is the first FDA-approved treatment for major depressive disorder (MDD) to have data showing a positive effect on processing speed, an aspect of cognitive function that is commonly impaired in patients with MDD.

The data now included on the Trintellix label are from two eight-week, randomized, placebo-controlled studies that showed vortioxetine was superior to placebo on the Digit Symbol Substitution Test (DSST), a neuropsychological test that measures processing speed. Both studies showed that vortioxetine was superior to placebo at improving performance on the DSST.

Further analysis also suggested that the medication had some direct effects on processing speed, and benefits were not solely due to alleviation of overall depressive symptoms. ■