FDA Actions
The FDA has approved the first drug to treat hypoactive sexual desire disorder in premenopausal women. Flibanserin is a serotonin 1A agonist and a serotonin 2A antagonist, although the mechanism by which the drug improves sexual desire and is related to stress is unknown. Given orally once daily at bedtime, 100 mg of flibanserin was evaluated in three 24-week, double-blind, placebo-controlled trials in about 2400 premenopausal women with an average age of 36. In the trials, women counted the number of satisfying sexual events, reported sexual desire over the preceding 4 weeks, and reported distress related to low sexual desire. On average, flibanserin increased the number of satisfying sexual events by 0.5-1 additional event per month over placebo. Sexual desire scores and sexual distress scores both improved. The drug comes with a boxed warning regarding the risk of severe hypotension and syncope, especially in women who drink alcohol or take a CYP3A4 inhibitor during treatment with flibanserin. The use of alcohol is contraindicated while taking the drug. The approval comes with the requirement for a risk evaluation and medication strategy due to the interaction with alcohol. The FDA is also requiring manufacturers to conduct three well-designed studies in women to understand the risk of the combination of flibanserin with alcohol. Because of the risk, the drug will only be available through certified pharmacies and may only be prescribed by certified prescribers. Flibanserin is marketed by Sprout Pharmaceuticals as Addyi. The cost of the drug has not been announced, but company officials have noted the cost will be roughly the equivalent of a month’s supply of male erectile dysfunction pills — speculated to be approximately $400 per month.
The FDA has approved rolapitant to prevent delayed phase chemotherapy-induced nausea and vomiting. It is approved for use in combination with other antiemetic agents. Rolapitant is a P/neurokinin 1 (NK-1) receptor antagonist with a plasma half-life of about 7 days. Approval was based on three randomized, double-blind, controlled trials where rolapitant was used in combination with granisetron and dexamethasone in patients receiving highly and moderately emetogenic chemotherapy. The use of rolapitant vs granisetron and dexamethasone alone resulted in greater reduction in vomiting and use of rescue medication during the delayed phase (24-120 hours). The most common side effects are neutropenia, hiccups, anorexia, and dizziness. Rolapitant joins aprepitant (Emend) as the second NK-1 antagonist approved for this indication. Rolapitant is marketed by Tesaro Inc as Varubi.
The DPP-4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin) used to treat type 2 diabetes may cause severe and disabling joint pain, according to the FDA. There have been 33 cases of severe arthralgia reported to FDA’s Adverse Event Reporting System from 2006-2013. About one-third of the patients required hospitalization for disabling pain. Arthralgia onset ranged from 1 day to years after imitation of a DPP-4 inhibitor. Symptoms generally resolved within a month after discontinuing medication. The FDA has added a new warning and precaution about this risk to the labels of all DPP-4 medications.
The FDA has approved evolocumab, the second PCSK9 inhibitor to lower LDL cholesterol in adults with familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease for whom current therapy options aren’t sufficient. Like alirocumab (Praluent), evolocumab is a monoclonal antibody that inhibits PCSK9, which augments LDL clearance through the liver. The drug is given by subcutaneous injection once or twice a month. Efficacy and safety were shown in one 52-week, placebo-controlled trial and eight 12-week, placebo-controlled trials, where evolocumab resulted in an average 60% lowering of LDL cholesterol compared to placebo. Side effects included upper respiratory infection symptoms and back pain. Neither evolocumab nor alirocumab have been shown to reduce the risk of cardiovascular disease; however, clinical trials are ongoing. Evolocumab is marketed by Amgen as Repatha. The drug is expected to cost more than $14,000 per year.
In this section: Drug to treat hypoactive sexual desire disorder in premenopausal women goes live; new drug available to prevent delayed phase chemotherapy-induced nausea and vomiting; DPP-4 inhibitors used to treat type 2 diabetes may cause severe and disabling joint pain; and evolocumab receives approval.
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