The FDA has approved a fixed-dose combination of the opioid receptor antagonist naltrexone (ReVia, and others) and the antidepressant and smoking cessation agent bupropion (Wellbutrin SR, Zyban, and others), as Contrave (Orexigen/Takeda) for weight loss. The combination was approved for use as an adjunct to diet and increased physical activity in patients with a body mass index (BMI) ≥30 kg/m2 or a BMI ≥27 kg/m2 and one or more weight-related comorbidities such as hypertension, diabetes, or dyslipidemia. Naltrexone/bupropion is not a controlled...

The FDA has approved a fixed-dose, orally inhaled combination of the long-acting anticholinergic tiotropium and the long-acting beta2-adrenergic agonist olodaterol (Stiolto Respimat — Boehringer Ingelheim) for long-term, once-daily, maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD). It is not approved for treatment of acute exacerbations of COPD or for treatment of asthma. Tiotropium (Spiriva Handihaler, Spiriva Respimat) and olodaterol (Striverdi Respimat) are also available separately for once-daily treatment of...

The injectable glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide, which was approved by the FDA as Mounjaro for treatment of type 2 diabetes in 2022, has now been approved as Zepbound (Lilly) for chronic weight management in adults who have a BMI ≥30 kg/m2 or a BMI ≥27 kg/m2 and at least one weight-related comorbidity. The injectable GLP-1 receptor agonists liraglutide (Saxenda) and semaglutide (Wegovy) are approved for chronic weight management in patients ≥12 years...

The recombinant respiratory syncytial virus (RSV) vaccine Arexvy (GSK) has now received FDA approval for use in adults 50-59 years old who are at increased risk for lower respiratory tract disease (LRTD) caused by RSV. It was previously approved only for adults ≥60 years old. Two other RSV vaccines have received FDA approval: Abrysvo, a recombinant vaccine that is licensed for use in adults ≥60 years old and in pregnant women at 32-36 weeks' gestation to prevent RSV-associated LRTD in their infants, and mResvia, an mRNA vaccine recently licensed for use in adults ≥60 years old...

Psoriatic arthritis is a chronic inflammatory arthropathy associated with psoriasis. A recent review found that about 20% of patients with psoriasis have psoriatic arthritis. Updated guidelines for treatment of psoriatic arthritis have recently been published.

Human alpha1-proteinase inhibitor (Prolastin Cutter), possibly better known as alpha1-antitypsin (ATT), is now available in the USA for replacement therapy in patients with emphysema who have a congential deficiency of the protein.

Pegademase (Adagen - Enzon), bovine adenosine deaminase (ADA) conjugated with polyethylene glycol (PEG), was recently approved by the US Food and Drug Administration as an 'orphan drug' for treatment of severe combined immunodeficiency disease (SCID). SCID due to inherited deficiency of ADA occurs in less than one per million births; until recently, without extraordinary isolation measures, it was usually fatal before the age of two.

Isradipine (DynaCirc - Sandoz), a dihydropyridine calcium-channel blocker chemically related to nicardipine (Cardene) and nifedipine (Procardia, and others), was recently approved by the US Food and Drug Administration for oral treatment of hypertension.

The Medical Letter continues to receive inquiries about the value of edetate disodium (EDTA) chelation therapy for cardiovascular disease. The last Medical Letter article on this subject was published in 1981 (volume 23, page 51). Some authors have estimated that more than 500,000 people receive this form of treatment each year (MT Grier and DG Meyers, Ann Pharmacother, 27:1504, Dec 1993).

Methadone, an opioid agonist that can be taken orally, has been used for maintenance treatment for many years in the USA (DM Novick et al, Drug Alcohol Depend, 33:235, 1993). Last year, the US Food and Drug Administration approved the distribution and use of L-alpha-acetyl-methadol (LAAM; ORLAAM - Bio Development Corporation, McLean, VA), a long-acting congener of methadone. LAAM, like methadone, will be available for this indication only through federal and state-regulated treatment programs.