FDA ACTIONS
December 1, 2014
The FDA has approved a new single entity hydrocodone product with abuse deterrent properties. The new hydrocodone product is indicated for pain severe enough to require daily, around-the-clock, long-term opioid therapy. The drug is not approved for short term or as-needed pain relief. The tablet is difficult to crush or dissolve and forms a thick hydrogel when tampered with that is difficult to inject. Hydrocodone extended release is manufactured by Purdue Pharma and is marketed as Hysingla ER. It is offered in 20, 30, 40, 60, 80, 100, and 120 mg strengths. This product offers an alternative to Zogenix’s Zohydro, also a single agent hydrocodone product, which was approved by the FDA last year and was roundly criticized because of lack of tamper-proof qualities. The maximum dose of Zohydro is 50 mg. Zogenix is working on their own tamper-proof tablet which may be marketed as within the next 6 months.
The FDA has “concerns” whether two generic versions of extended-release methylphenidate (Concerta) are therapeutically equivalent to the brand-name drug. Methylphenidate is used to treat attention-deficit hyperactivity disorder in adults and children. The two approved generics manufactured by Mallinckrodt and Kudco Ireland Ltd “may deliver the drug in the body at a slower rated during the 7-12 hour range” according to the FDA statement. Janssen, the manufacturer of brand name Concerta also makes an authorized generic marketed by Actavis that is identical to the original product and has been found to be bioequivalent. The two generics of concern will stay on the market and patients should stay on the drugs unless the drug is not providing the desired effect.
The FDA’s Endocrinologic and Metabolic Drug Advisory Committee has reviewed liraglutide for the new indication of weight management and found it to be safe and effective enough to warrant approval. Liraglutide, a GLP-1-receptor agonist, is currently marketed by Novo Nordisk as Victoza for the treatment of type 2 diabetes. Studies presented to the committee showed that obese patients who injected 3 mg of liraglutide daily lost at least 5% of body weight, including 22% of participants who lost 10%. There was concern voiced by one reviewer regarding an imbalance in the number of breast cancers in women taking the drug and there has also been lingering concerns about thyroid cancers, but the committee felt that these issues could be studied in post-marketing studies. If approved by the FDA for weight loss, liraglutide will be marketed for that indication as Saxenda.
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