FDA Approves New Drugs for Pain

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FDA Updates

Belbuca, buccal-administered buprenorphine, has received U.S. Food and Drug Administration (FDA) approval for treating severe chronic pain.¹ The dosage form is a dissolving film that is absorbed through the inner lining of the cheek for chronic pain management. It’s expected to be commercially available in the first quarter of 2016. Seven dosage strengths will be available for flexibility. Doses will range from 75 μg to 900 μg to be administered every 12 hours.

The FDA has approved meloxicam capsules (Vivlodex) for managing osteo­arthritis (OA) pain.² It will be available in 5 mg and 10 mg doses for once-daily usage. This formulation uses low-dose pro­prietary SoluMatrix Fine Particle Technology with submicron meloxicam particles that are approximately 10 times smaller than their original size, resulting in faster dissolution. The Phase 3 clinical trial, from which the data that support the approval of this formulation were derived, was a 12-week multicenter, double-blind, placebo-controlled study of patients aged 40 and older (n=402) with OA pain of the knee or hip.

Lesurinad, a selective uric acid reabsorption inhibitor (SUI), was recommended for approval by an independent panel of FDA advisors for treating gout in a vote of 10 to 4.³ For primary issue, two doses were tested: 200 mg and 400 mg. The 400 mg dose was more effective at treating gout, but was also associated with more renal and cardio­vascular adverse events.

The manufacturer submitted only the 200 mg dose for approval, which was granted on Dec. 22, 2015, under the brand name Zurampic.⁴ The approved indication is for use in combination with a xanthine oxidase inhibitor, for treating hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone.

There are still safety concerns with the 200 mg dose. The FDA safety profile vote resulted in a slim margin of approval: Seven to six, with one abstention. Zurampic carries a boxed warning related to acute renal failure with recommendations to monitor renal function throughout treatment. In addition, the agent should not be used as monotherapy.

The FDA has granted tentative approval for extended-release, abuse-deterrent oxycodone capsules (Xtampza ER) to manage pain severe enough to require around-the-clock, long-term opioid treatment for patients who find alternative treatments inadequate.⁵ The FDA determined that this product meets all the required safety, quality and efficacy standards for approval, but the approval is tentative due to ongoing litigation with Purdue Pharma (filed in March 2015). The product has received an automatic 30-month stay or availability hold. The FDA can provide final approval for the drug only if the litigation is resolved prior to the expiration of the 30-month period.