FDA Actions
May 1, 2014
The FDA has approved apremilast for the treatment of psoriatic arthritis. The drug is a phosphodiesterase-4 inhibitor that is taken orally, the first non-steroid oral drug available for this indication. The drug was approved on the basis of three clinical trials of nearly 1500 patients with psoriatic arthritis which showed that the drug improved the signs and symptoms of psoriatic arthritis. Common side effects included weight loss, diarrhea, nausea, and headache. The drug was also associated with an increase in depression. Apremilast is marketed by Celgene Corporation as Otezla.
The FDA has approved apixaban (Eliquis) for prophylaxis of deep vein thrombosis in patients who have undergone knee or hip replacement. The drug is already approved for stroke prevention in patients with non-valvular atrial fibrillation. The new indication was based on results of the ADVANCE trial in which apixaban was compared to enoxaparin in 11,000 postoperative joint patients. Apixaban joins rivaroxaban as the second novel oral anticoagulant with this indication.
The FDA has approved an auto-injector formulation of naloxone for the treatment of suspected opioid overdoses. The product is designed for caregivers and family members and is small enough to be carried in a pocket or stored in a medicine cabinet. Once turned on, the auto-injector provides verbal instructions on how to deliver the drug, similar to defibrillators. The drug is formulated to be given intramuscularly or subcutaneously. Repeat doses may be needed since many opioids have a longer half life than naloxone. Medical care should be sought after administration. Naloxone auto-injector is manufactured by kaleo Inc. as Evzio.
FDA Commissioner Margaret A. Hamburg has issued a Statement on Prescription Opioid Abuse to address “misuse, abuse, addiction, and overdose of opioid analgesics” as well as assuring appropriate prescribing. Among a number of recommendations that include education, more research, and better labeling, the commissioner again suggests that hydrocodone-containing combination products move from Schedule III to the more restrictive Schedule II. This would require a handwritten, non-tamper proof prescription for some of the most widely used pain relievers including Vicodin and Norco.
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