The FDA has approved suzetrigine (Journavx – Vertex), a selective sodium channel blocker, for oral treatment of moderate to severe acute pain in adults. Suzetrigine is the first sodium channel blocker to be approved in the US for this indication and the first oral nonopioid drug to be approved for treatment of pain in over 25 years.

The injectable interleukin (IL)-23 antagonist guselkumab (Tremfya – Janssen Biotech) has now been approved by the FDA for treatment of moderately to severely active Crohn's disease (CD) in adults; it was approved earlier for treatment of ulcerative colitis (UC), plaque psoriasis, and psoriatic arthritis. The IL-23 antagonists risankizumab (Skyrizi) and mirikizumab (Omvoh) and the IL-12/23 antagonist ustekinumab (Stelara, and biosimilars) are also approved for treatment of CD.

In overactive bladder, involuntary bladder contractions due to detrusor overactivity result in urinary urgency, frequency, nocturia, and incontinence. The prevalence of the disorder increases with age. Nonpharmacologic treatment, including bladder training, urge suppression, pelvic floor muscle exercises, constipation management, modification of fluid intake, and avoidance of dietary irritants such as alcohol and caffeine, should be tried first.

The US Food and Drug Administration recently approved the marketing of G-CSF (recombinant human granulocyte colony-stimulating factor, generic name filgrastim, Neupogen - Amgen) and GM-CSF (recombinant human granulocyte-macrophage colony-stimulating factor, generic name sargramostim, Leukine - Immunex, Prokine - Hoechst-Roussel). G-CSF is approved for use after cancer chemotherapy in patients with non-myeloid malignancies to decrease the incidence of infection. GM-CSF is approved for acceleration of myeloid recovery after autologous bone marrow transplantation in non-Hodgkin's lymphoma,...

Intravenous formulations of immune globulin (IVIG) have been available for more than ten years for treatment of immune deficiency (Medical Letter, 24:81, 1982). Seven preparations are now licensed in the USA, with additional indications for their use.

Leflunomide (Arava - Hoechst Marion Roussel), which inhibits pyrimidine synthesis, and etanercept (Enbrel - Immunex/Wyeth-Ayerst), which blocks the action of tumor necrosis factor (TNF), have been approved by the FDA for treatment of rheumatoid arthritis. A third drug, infliximab (Remicade - Centocor), which also blocks TNF and has been used to treat rheumatoid arthritis, was approved earlier for treatment of Crohn's disease. Its use in Crohn's disease will be reviewed in a future issue.

Combination antiretroviral therapy including protease inhibitors has dramatically changed the treatment of HIV infection and the prognosis of those affected (Medical Letter Handbook of Antimicrobial Therapy, 1998, page 122). Due to limitations and failures with these drugs in many patients, however, three new drugs, none of them protease inhibitors, have rapidly come into wide use in clinical trials or 'expanded access' programs. They are abacavir (Ziagen - Glaxo Wellcome), adefovir (Preveon - Gilead) and efavirenz (Sustiva - DuPont). Efavirenz was recently approved for treatment of...

Levalbuterol, the R-isomer of racemic albuterol, has been approved by the FDA for prevention and treatment of bronchospasm in patients at least 12 years old.

Oxcarbazepine, which is chemically similar to carbamazepine, and levetiracetam, a pyrrolidine acetamide chemically unrelated to other antiepileptic drugs, are the sixth and seventh drugs approved by the US Food and Drug Administration in the last five years for oral use in partial seizures.

Meloxicam, a nonsteroidal anti-inflammatory drug (NSAID) with some cyclooxygenase-2 (COX-2) selectivity in vitro, has been approved by the FDA for treatment of osteoarthritis.