View the Expanded Table: Some Drugs for Chronic Idiopathic Constipation

The FDA has approved evinacumab-dgnb (Evkeeza – Regeneron), an angiopoietin-like 3 (ANGPTL3) inhibitor, for adjunctive IV treatment of homozygous familial hypercholesterolemia (HoFH) in patients ≥12 years old. Evinacumab is the first ANGPTL3 inhibitor to be approved in the US.

Ropinirole (Requip - GlaxoSmithKline), a dopamine agonist already available for treatment of Parkinson's disease, is now the first drug approved by the FDA for treatment of moderate to severe restless legs syndrome (RLS).

Pharmacologic management of opioid withdrawal symptoms can reduce the intensity of drug craving and improve treatment retention in patients with opioid use disorder who will receive maintenance treatment. Withdrawal management without subsequent maintenance treatment is associated with high rates of relapse, overdose death, and HIV and/or hepatitis C virus infection. Several guidelines on management of opioid withdrawal are available. Maintenance treatment of opioid use disorder was reviewed in a previous issue.

Donepezil hydrochloride (Aricept - Eisai), a piperidine-based acetylcholinesterase inhibitor, is now being marketed for oral treatment of cognitive symptoms in patients with mild to moderate dementia due to Alzheimer's disease. Donepezil is the second drug approved for this indication; tacrine hydrochloride (Cognex), also an acetylcholinesterase inhibitor, has been available in the USA for four years (Medical Letter, 35:87, 1993).

The FDA has approved a new interferon beta-1b product (Extavia – Novartis) for treatment of relapsing forms of multiple sclerosis (MS). Extavia is identical to Betaseron (Bayer); both are produced in the same factory and packaged separately.

The FDA has approved tafamidis, an oral transthyretin stabilizer, in 2 different formulations (see Table 1) for treatment of adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). Tafamidis is the first drug to be approved in the US for this indication. Patisiran (Onpattro), a transthyretin-directed small interfering RNA, and inotersen (Tegsedi), a transthyretin-directed antisense oligonucleotide, were both recently approved for hereditary transthyretin amyloid polyneuropathy.THE DISEASE — ATTR-CM is a progressive life-threatening disease caused by destabilization of the...

The FDA has expanded its Emergency Use Authorization for the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax to include its use as a first booster dose in adults who completed a primary series with any COVID-19 vaccine ≥6 months previously and are unable or unwilling to receive a booster dose of a bivalent mRNA vaccine. The Novavax vaccine is not authorized for use in persons who have received a booster dose of any other COVID-19 vaccine.

Bupropion (Wellbutrin - Burroughs Wellcome) was recently marketed in the USA for treatment of depression. First approved by the Food and Drug Administration in late 1985, the drug was withdrawn from the market in early 1986 because of a high incidence of seizures in one study.

Topiramate (Topamax - Ortho-McNeil) has been approved by the US Food and Drug Administration (FDA) for oral use as an adjunct to other drugs in adult patients with partial seizures. Since this diagnostic category includes the largest number of patients with refractory epilepsy, new drugs with antiepileptic activity are usually tried first for this indication. Topiramate (toe pyre' a mate) is a structurally unique agent chemically related to the D-enantiomer of fructose.