The FDA has approved stiripentol (Diacomit – Biocodex) for treatment of seizures in patients ≥2 years old with Dravet syndrome who are also taking clobazam (Onfi). Stiripentol, which has been available in Europe, Canada, and Japan for many years, is the second drug to be approved in the US for this indication; cannabidiol oral solution (Epidiolex), a purified marijuana product, was the first.

Rufinamide (Banzel - Eisai), a triazole derivative structurally unrelated to other marketed antiepileptic drugs (AEDs), has been approved by the FDA for treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients ≥4 years old.

Duloxetine hydrochloride (Cymbalta - Lilly), a selective serotonin and norepinephrine reuptake inhibitor (SNRI), has been approved by the FDA for treatment of major depressive disorder in adults, and more recently for diabetic peripheral neuropathy as well. The Medical Letter will review its role in diabetic neuropathy in a future issue.

Atazanavir (Reyataz - Bristol-Myers Squibb), a new protease inhibitor (PI), and emtricitabine (Emtriva - Gilead), a nucleoside analogue reverse transcriptase inhibitor (NRTI) chemically similar to lamivudine, have been approved by the FDA for treatment of HIV-1 infection. Both are taken once daily, unlike most anti-HIV drugs.

The FDA has approved pomalidomide (Pomalyst – Celgene), an oral thalidomide analog, for treatment of patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide (Revlimid) and bortezomib (Velcade) and whose disease had progressed on or within 60 days of completion of the last therapy.

In recent years, many women have become concerned about the safety of pharmaceutical replacement hormones for treatment of menopausal symptoms. “Bioidentical” hormone preparations, which are not approved by the FDA, are heavily promoted in popular books and on TV as alternatives; these are derivatives of soy or plant extracts, chemically modified to be structurally identical to endogenous hormones. Most FDA-approved single-entity hormones are also derivatives of soy or plant extracts and are structurally identical to hormones produced by the ovary.

Vardenafil (Levitra -Bayer) is the second oral drug approved by the FDA for treatment of erectile dysfunction. Sildenafil (Viagra - Medical Letter 1998; 40:51), the first oral drug, has been available for 5 years. Pharmacokinetics, effectiveness, adverse effects, dosage and cost of the new drug are reviewed. Whether it offers any benefits over sildenafil is discussed.

Olopatadine 0.6% nasal spray (Patanase - Alcon) has been approved by the FDA for treatment of seasonal allergic rhinitis in patients ≥ 12 years old. An H1-antihistamine with mast-cell stabilizing activity, olopatadine is already marketed for treatment of allergic conjunctivitis in a 0.1% solution as Patanol and in a 0.2% solution as Pataday. Azelastine (Astelin), another H1-antihistamine with mast-cell stabilizing activity, has been available for intranasal treatment of allergic rhinitis since 1997.

The FDA has approved vedolizumab (Entyvio - Takeda), an intravenous integrin receptor antagonist, for treatment of moderate to severe ulcerative colitis or Crohn's disease in adults who have not responded to, lost response to, or cannot tolerate standard treatment. Natalizumab (Tysabri), another integrin receptor antagonist, has been available for several years for treatment of Crohn's disease and multiple sclerosis.

Cobicistat, a pharmacokinetic enhancer that boosts levels of some HIV drugs but has no antiretroviral activity of its own, is now available alone as Tybost (Gilead) and in fixed-dose combinations with the protease inhibitors atazanavir (Evotaz — BMS) and darunavir (Prezcobix — Janssen) for treatment of HIV-1 infection. Both atazanavir and darunavir have traditionally been used in combination with the CYP3A inhibitor ritonavir (Norvir) to boost their serum concentrations, but neither is available in a fixed-dose combination with ritonavir.