The FDA has approved vorapaxar (Zontivity – Merck), an oral protease-activated receptor-1 (PAR-1) antagonist, for use with aspirin and/or clopidogrel to reduce the risk of thrombotic cardiovascular events in patients with peripheral arterial disease or a history of myocardial infarction (MI). It is the first PAR-1 antagonist to be approved by the FDA.

The FDA has approved Liletta, an intrauterine device (IUD) that releases the synthetic progestin levonorgestrel, for prevention of pregnancy for up to 3 years. The fourth IUD to be approved in the US, and the third that releases levonorgestrel, Liletta is comarketed by Actavis and Medicines360, a nonprofit women's health pharmaceutical company. The wholesale cost of Liletta is similar to that of other IUDs (see Table 1), but the manufacturer offers programs that significantly reduce the cost for commercially-insured patients and clinics serving low-income women.

The FDA has approved a manually injected, single-dose, prefilled epinephrine syringe (Symjepi – Adamis/Sandoz) for emergency treatment of anaphylaxis. The new device is approved in 0.3- and 0.15-mg strengths for treatment of patients weighing ≥30 kg and 15 to 30 kg, respectively; only the 0.3-mg strength is currently available. According to Sandoz, Symjepi will be made available first to institutions and later to the retail market.

About 60% of men ≥60 years old have clinically relevant prostatic enlargement due to benign prostatic hyperplasia (BPH). The goals of treatment are to decrease lower urinary tract symptoms and to prevent disease progression and complications such as acute urinary retention. The American Urologic Association's guidelines for treatment of BPH were recently updated.

Naltrexone (ReVia -DuPont Pharma), a long-acting oral opioid antagonist previously marketed for treatment of opioid dependence under the trade name Trexan, was recently approved by the US Food and Drug Administration (FDA) for treatment of alcohol dependence. The new trade name will now also be used for the old indication.

Two controlled-release formulations of triptorelin (trip toe rel' in) pamoate, an agonist analog of human luteinizing hormone-releasing hormone (LHRH), are now available in the US for parenteral treatment of advanced prostate cancer. Trelstar Depot is given every 4 weeks and Trelstar LA every 12 weeks. Triptorelin has been available in some countries since 1986.

Methamphetamine, a highly addictive synthetic sympathomimetic, has again become important as a drug of abuse in the US. Its resurgence has been associated with unsafe sexual practices that have resulted in an increase in HIV transmission, particularly among men who have sex with men (SJ Semple et al, J Subst Abuse Treat 2002; 22:149; A Urbina and K Jones, Clin Infect Dis 2004; 38:890).

The main purpose of vasopressors is to raise arterial blood pressure, while that of inotropes is to increase cardiac contractility. The choice of drugs is dictated by the clinical setting. Controlled trials comparing the efficacy and safety of these drugs are generally lacking.

The FDA has approved a fixed-dose extended-release formulation of oxycodone and acetaminophen (Xartemis XR – Mallinckrodt) for oral treatment of acute pain severe enough to require an opioid. Oxycodone is available in the US as a single entity in oral immediate-release (Oxecta, and others) and extendedrelease (OxyContin) formulations. Immediate-release oxycodone is also available in combination with aspirin (Percodan, and others), acetaminophen (Percocet, and others), or ibuprofen (see Table 1).

The FDA has approved Xtampza ER (Collegium), a new extended-release, abuse-deterrent capsule formulation of oxycodone, for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.