FDA Actions
September 1, 2014
As anticipated, the FDA and the Drug Enforcement Administration (DEA) have moved hydrocodone-combination products (Vicodin, Lortab, Norco, and others) from Schedule III to the more restrictive Schedule II category with an implementation date of early October. The move puts hydrocodone products in the same category as morphine, oxycodone, fentanyl, dilaudid, and methadone. This action was taken to counter the growing problem of prescription opioid abuse and overdoses, which has reached epidemic proportions in the United States in recent years. Non-combination hydrocodone is already Schedule II. Among other changes, the new rule will require a written, tamper-proof prescription for every fill of hydrocodone-combination products. No phone prescriptions will be allowed and refills are not allowed. The new category also strengthens penalties for diversion and requires increased security for storage in pharmacies. The new rule is expected to put pressure on physicians who treat pain patients as well as pharmacies that dispense these drugs — dramatically increasing foot traffic and visits. Some patient advocates argued that chronic pain patients will also be affected by the new rule.
The FDA has approved apixaban (Eliquis) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) and for the reduction in the risk of recurrent DVT and PE after initial therapy. The drug is already approved for stroke prevention in patients with non-valvular afib as well as for prophylaxis of DVT and PE in patients who have undergone hip or knee replacement surgery. The other drugs in this category — rivaroxaban (Xarelto) and dabigatran (Pradaxa) — are already approved for this indication.
The FDA has approved a novel new drug to treat insomnia. Suvorexant is an antagonist of orexin receptors, which regulate sleep-wake cycles. Approval was based on three clinical trials of more than 500 patients. The drug was associated with falling asleep faster and longer time asleep compared to placebo. The drug is Schedule IV and comes with a warning regarding daytime somnolence, including impaired driving, especially with higher doses. It should be taken at bedtime with at least 7 hours before planned awakening. There is also a warning regarding dependence and complex behaviors while not fully awake including driving, preparing food, making phone calls, or having sex. The drug is supplied in 5, 10, 15, and 20 mg strengths with the lowest effective dose recommended. Suvorexant is made by Merck, Sharpe & Dohme Corporation and marketed as Belsomra.
The FDA has approved oritavancin, the third new antibiotic to treat skin and skin structure infections caused by susceptible bacteria including Staphylococcus aureus(including methicillin-susceptible and methicillin-resistant strains), Streptococcusspecies and Enterococcus faecalis. Oritavancin is administered intravenously as a single 3-hour infusion. The single-dose regimen was compared to intravenous vancomycin for 7-10 days and was shown to be of equal efficacy. Oritavancin is the third new antibiotic approved for this indication after dalbavancin (Dalvance) and tedizolid (Sivextro). All three were approved as qualified infectious disease products, and hence given a priority review and an additional 5 years of market exclusivity beyond the normal patent life. Oritavancin is marketed by The Medicines Company as Orbactiv.
The FDA has approved the third inhibitor of sodium-glucose transport protein (SGLT2) for the treatment of type 2 diabetes. Empagliflozin follows canagliflozin (Invokana) and dapagliflozin (Farxiga) in this class of antidiabetic drugs that block glucose reabsorption in the kidneys, allowing glucose to be eliminated in the urine, thus lowering blood sugar levels. The drug can be used alone or in combination with other antidiabetic medications. The drug was approved on the strength of seven clinical trials of nearly 4500 patients with type 2 diabetes which showed that the drug modestly lowered HbA1c levels. Empagliflozin is not for treatment of type 1 diabetics. The FDA is requiring postmarketing studies on cardiovascular outcomes as well as use in children. The most common side effects are urinary tract infections and female genital infections. Empagliflozin is manufactured by Boehringer Ingelheim as Jardiance.
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