An injectable extended-release formulation of the opioid-receptor antagonist naltrexone (Vivitrol - Alkermes/Cephalon) has been approved by the FDA for once-monthly use, along with psychosocial support, to maintain abstinence from alcohol. Naltrexone inhibits the rewarding effects of alcohol. Oral naltrexone (Revia, and others) has been approved for treatment of alcohol dependence since 1994, but poor adherence has limited its effectiveness. In the new extended-release (XR) formulation, naltrexone is encapsulated in polylactide-co-glycolide microspheres (similar to absorbable suture material)...

Dasatinib (Sprycel - Bristol-Myers Squibb), an inhibitor of multiple tyrosine kinases, has been approved by the FDA for second-line treatment of chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in adults.

Ciclesonide (Omnaris - Sepracor/Nycomed), a once daily corticosteroid nasal spray, is now available for treatment of seasonal allergic rhinitis (SAR) in adults and children ≥6 years old and for perennial allergic rhinitis (PAR) in those ≥12 years old. An orally inhaled formulation of ciclesonide (Alvesco) was recently approved by the FDA for maintenance treatment of asthma, and will be reviewed in a future issue of The Medical Letter

The FDA has approved tofacitinib (toe” fa sye’ ti nib; Xeljanz – Pfizer), an oral Janus kinase (JAK) inhibitor, for treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to or are intolerant of methotrexate. Ruxolitinib (Jakafi) is the only other JAK inhibitor available in the US; it is FDA-approved for treatment of myelofibrosis.

The FDA has approved oritavancin (Orbactiv – The Medicines Company), a long-acting lipoglycopeptide antibiotic given as a single intravenous (IV) dose, for treatment of acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria in adults. It is the third lipoglycopeptide antibiotic to be marketed in the US; telavancin (Vibativ) and dalbavancin (Dalvance) were approved earlier.

Olodaterol (Striverdi Respimat – Boehringer Ingelheim), a new inhaled long-acting beta2-agonist, has been approved by the FDA for once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). It is not approved for treatment of acute exacerbations of COPD or for treatment of asthma. Olodaterol is the third long-acting beta2-agonist to be approved by the FDA for once-daily use; indacaterol (Arcapta Neohaler), which is available as a single agent, and vilanterol, which is available only in fixed-dose combinations with the...

The FDA has approved Namzaric (Forest), a fixed-dose combination of extended-release (ER) memantine (Namenda XR), an NMDA-receptor antagonist, and donepezil (Aricept, and generics), an acetylcholinesterase inhibitor, for treatment of moderate to severe Alzheimer's type dementia in patients previously stabilized on both drugs. The patent for Namenda has recently expired and generic formulations of memantine 5- and 10-mg tablets have been approved.

The FDA has approved Apadaz (KemPharm), a short-acting, fixed-dose combination of benzhydrocodone and acetaminophen, for short-term management (≤14 days) of acute pain severe enough to require an opioid and for which alternative treatment options are inadequate. Benzhydrocodone is a prodrug of hydrocodone. Fixed-dose combinations of short-acting hydrocodone and acetaminophen or ibuprofen have been available for years and are the most abused opioid products in the US. Apadaz was developed under the presumption that inclusion of the inactive prodrug would reduce the potential for...

The FDA has approved upadacitinib (Rinvoq – Abbvie), an oral Janus kinase (JAK) inhibitor, for treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to or cannot tolerate methotrexate (Trexall, and others). Upadacitinib is the third JAK inhibitor to be approved in the US for treatment of RA; tofacitinib (Xeljanz, Xeljanz XR) and baricitinib (Olumiant) were approved earlier.

Atogepant (Qulipta – Abbvie), an oral small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist ("gepant"), has been approved by the FDA for prevention of episodic migraine in adults. It is the second oral CGRP receptor antagonist to be approved in the US for this indication; the first was rimegepant (Nurtec ODT), which is also approved for acute treatment of migraine. Parenteral CGRP monoclonal antibodies are approved for prevention of migraine (see Table 3).