The FDA has approved an agonist/antagonist combination of morphine and naltrexone (Embeda – King) for treatment of chronic moderate to severe pain requiring around-the-clock analgesia for an extended period of time. The addition of naltrexone is intended to prevent abuse of morphine.

The equivalence of generic drugs to their brand-name precursors continues to be controversial. The last Medical Letter review of this subject (2002) concluded that well-documented therapeutic inequivalence between brand-name and FDA-approved generic drugs had not been reported. Is that still true? New data have become available for some drugs.

Asenapine (Saphris - Schering-Plough), a dibenzo-oxepino pyrrole, has been approved by the FDA in a sublingual tablet formulation for acute treatment of schizophrenia and manic or mixed episodes associated with bipolar disorder. It is the sixth second-generation antipsychotic approved by the FDA for use in bipolar disorder.

The FDA has approved plerixafor (Mozobil – Genzyme), a CXCR4 chemokine receptor antagonist, for use in combination with granulocyte-colony stimulating factor (G-CSF; Neupogen) to mobilize peripheral blood stem cells in adults with multiple myeloma or non-Hodgkin’s lymphoma before high-dose chemotherapy with autologous stem cell rescue.

A Medical Letter reader recently received a diagnosis of athlete’s foot and a prescription for Naftin gel, for which his pharmacy charged $145, and his insurance company required a $70 copay because this formulation was not included in its formulary. Do patients need to pay prices like these to treat tinea pedis?

The FDA has approved a recombinant human papillomavirus (HPV) vaccine (Cervarix – GlaxoSmithKline) for use in girls and women 10-25 years old to prevent infection with HPV types 16 and 18, which have been associated with cervical cancer. A recombinant quadrivalent HPV vaccine (Gardasil – Merck) already on the market in the US prevents infection with HPV types 6, 11, 16 and 18.

The FDA has approved tocilizumab (Actemra – Genentech; RoActemra in Europe) for intravenous (IV) treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to tumor necrosis factor (TNF) inhibitors.

Sumatriptan was first marketed in the US in 1993 as Imitrex for subcutaneous injection, followed by tablets for oral administration and then by a nasal spray. It is one of seven serotonin receptor agonists (“triptans”) marketed in the US for treatment of migraine, but it is the only one available for subcutaneous injection. Now the FDA has approved Sumavel DosePro> (Zogenix), a needle-free device for delivering sumatriptan succinate to subcutaneous tissue, for treatment of migraine and cluster headache in adults.

The FDA has approved an inhaled fixed-dose combination (Breo Ellipta – GSK/Theravance) of the corticosteroid fluticasone furoate and the long-acting beta₂-adrenergic agonist (LABA) vilanterol trifenatate for once-daily treatment of chronic obstructive pulmonary disease (COPD).

The FDA has approved an intranasal gel formulation of testosterone (Natesto – Trimel/Endo) for replacement therapy in men with hypogonadism. Packaged in a metered-dose pump, Natesto is the first intranasal testosterone to become available in the US. Like other testosterone products, it is classified as a schedule III controlled substance. The FDA recently cautioned against using testosterone to treat low testosterone levels solely due to aging because the benefits and safety of such use have not been established, and there is a possible increased risk of myocardial infarction...