Zolpidem (Ambien - Sanofi-Aventis), a nonbenzodiazepine benzodiazepine receptor agonist, is the most frequently prescribed hypnotic in the US. As its patent approaches expiration, its manufacturer has received FDA approval to market an extended-release formulation of the drug, Ambien CR. The pharmacological rationale for doing so is that short-acting hypnotics like zolpidem are more effective at inducing sleep than they are at maintaining it.

A recombinant quadrivalent human-papillomavirus-like particle vaccine, Gardasil (Merck), has been approved by the FDA for use in girls and women 9-26 years old to prevent diseases associated with infection with human papillomavirus (HPV) types 6, 11, 16, and 18, including genital warts, precancerous cervical, vaginal or vulvar lesions, and cervical cancer.

Oxymorphone hydrochloride, a semi-synthetic opioid agonist, has been available for many years in the US as Numorphan (Endo) for parenteral use and as a rectal suppository. Now it has been approved by the FDA for oral administration as an immediate-release (IR) tablet (Opana) for treatment of moderate to severe acute pain, and as an extended-release tablet (Opana ER) for treatment of moderate to severe pain in patients requiring continuous opioid treatment for an extended period of time.

The FDA has approved the marketing of sinecatechins (Veregen - Bradley/Medigene), a botanical drug product, for treatment of external genital and perianal warts. Sinecatechins is a water extract of green tea leaves from Camellia sinensis. It is a mixture of catechins and other green tea components.

Nilotinib (Tasigna - Novartis), a tyrosine kinase inhibitor, has been approved by the FDA for treatment of Philadelphia chromosome-positive (Ph+) chronic or accelerated phase chronic myelogenous leukemia (CML) in patients resistant to or intolerant of imatinib (Gleevec).

The FDA has approved naloxegol (Movantik – AstraZeneca), a pegylated derivative of the opioid antagonist naloxone, for oral treatment of opioid-induced constipation in adults with chronic noncancer pain. It is the only oral opioid antagonist approved for this indication in the US.

The FDA has approved extended-release (ER) calcifediol (25-hydroxyvitamin D3; Rayaldee – Opko), a prohormone of calcitriol, the active form of vitamin D3. It is indicated for treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) who have serum total 25-hydroxyvitamin D levels <30 ng/mL.

The FDA has approved the monoamine oxidase type B (MAO-B) inhibitor safinamide (Xadago – US Worldmeds) as an adjunct to levodopa/carbidopa for management of "off" episodes in patients with Parkinson’s disease (PD). It is the first reversible MAO-B inhibitor to be approved for this indication. Selegiline (Eldepryl, and others) and rasagiline (Azilect, and generics), two irreversible MAO-B inhibitors, have been used alone and as adjuncts to levodopa/carbidopa for many years. Safinamide is not approved for use as monotherapy.

The FDA has approved solriamfetol (Sunosi – Jazz), a dopamine and norepinephrine reuptake inhibitor (DNRI), to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA). Pitolisant (Wakix), an H3-receptor antagonist/inverse agonist recently approved by the FDA for treatment of excessive daytime sleepiness in patients with narcolepsy, will be reviewed in a future issue.

The FDA has approved Seglentis (Esteve/Kowa), an oral combination of tramadol hydrochloride, a weak opioid agonist and weak serotonin and norepinephrine reuptake inhibitor (SNRI), and celecoxib, a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID), for use in adults with acute pain that is severe enough to require an opioid and for which alternative treatment options are inadequate.