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.

Pregabalin (Lyrica - Pfizer), a structural analog of gamma-aminobutyric acid (GABA) similar to gabapentin (Neurontin - Pfizer, and others), which recently became available generically, has been approved by the FDA for treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and diabetic peripheral neuropathy (DPN), and for adjunctive treatment of partial onset seizures in adults with epilepsy.

The FDA has approved the marketing of desvenlafaxine (Pristiq - Wyeth), the main active metabolite of venlafaxine (Effexor, and others - Wyeth), for treatment of major depressive disorder. Venlafaxine, a norepinephrine and serotonin reuptake inhibitor (SNRI), is available generically as an immediate-release tablet. Venlafaxine extended-release capsules (Effexor XR) are scheduled to go off-patent in 2010.

Milnacipran (Savella - Forest), an oral selective serotonin and norepinephrine reuptake inhibitor (SNRI), is the third drug approved by the FDA for management of fibromyalgia. The 2 others are pregabalin, a gammaaminobutyric acid (GABA) analog also approved for treatment of diabetic neuropathy, post-herpetic neuralgia and epilepsy, and duloxetine, an SNRI also approved for treatment of depression, diabetic neuropathy and generalized anxiety disorder.

The FDA has approved Odefsey (Gilead), a once-daily, fixed-dose combination of the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine and the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection in patients with HIV-1 RNA (viral load) ≤100,000 copies/mL or to replace a stable antiretroviral regimen in patients who have been virologically suppressed (viral load <50 copies/mL) for at least six months with no history of treatment failure.

The FDA has approved a fixed-dose combination of the long-acting anticholinergic glycopyrrolate and the long-acting beta2-adrenergic agonist (LABA) formoterol (Bevespi Aerosphere – AstraZeneca) for long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Glycopyrrolate/formoterol is the fourth long-acting anticholinergic/LABA combination to be approved in the US, but the first to become available in a metered-dose inhaler. Glycopyrrolate/indacaterol (Utibron Neohaler), umeclidinium/vilanterol (Anoro Ellipta), and tiotropium/olodaterol (Stiolto...

The FDA has approved three new once-daily fixed-dose antiretroviral drug combinations for treatment of HIV-1 infection. Symfi and Symfi Lo (Mylan) contain the non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz and the nucleoside reverse transcriptase inhibitors (NRTIs) lamivudine and tenofovir disoproxil fumarate (TDF) and were approved as complete antiretroviral regimens. Symfi Lo contains a lower dose of efavirenz than both Symfi and Atripla, a fixed-dose combination of efavirenz, TDF, and the NRTI emtricitabine that was approved in 2006. Cimduo (Mylan), which...

The FDA has approved Jornay PM (Ironshore), a capsule formulation of methylphenidate with a delayed-release outer layer and an extended-release inner layer, for once-nightly treatment of attention-deficit hyperactivity disorder (ADHD) in patients >6 years old. Jornay PM is the first methylphenidate product to become available in the US that is taken in the evening; other long-acting methylphenidate formulations are taken in the morning. It is being marketed specifically for patients who have disruptive ADHD symptoms in the morning.

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.

The choice of drugs for treatment of pneumonia depends on the most likely pathogens causing the infection and local antimicrobial resistance patterns. Factors such as severity of illness, presence of co-morbid conditions and whether the infection is community or hospital-acquired also need to be considered.