The FDA has approved lurasidone (Latuda - Sunovion), a new second-generation antipsychotic, for oral treatment of schizophrenia in adults.

The FDA has approved a transmucosal tablet formulation of fentanyl citrate (Fentora - Cephalon) for management of breakthrough pain in opioid-tolerant patients with cancer. An oral transmucosal fentanyl lozenge on a stick (Actiq, and others) is also available for this indication, and is widely used off-label for chronic, non-cancer pain as well.

Three low-dose transdermal estrogens were recently approved by the FDA for treatment of menopausal vasomotor symptoms. Elestrin and Divigel are transdermal estradiol gels and Evamist is an estradiol spray. Elestrin has been marketed in Europe since 1976.

Memantine hydrochloride, which has been used to treat dementia in Germany (Axura Merz) since 1982, has become the latest word-of-mouth miracle drug for Alzheimer's disease in the US (G Kolata, NY Times, June 15, 2003). Forest Laboratories has submitted a New Drug Application to the FDA for memantine. This review describes the standard treatment for Alzheimer's Disease, mechanism of action, clinical studies, adverse effects and dosage. Also included are sections on availability of the drug and how some people are obtaining memantine from abroad.

The FDA has approved ciltacabtagene autoleucel (Carvykti – Janssen), a B-cell maturation antigen (BCMA)-directed genetically-modified cellular product, for treatment of relapsed or refractory multiple myeloma in adults who received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Carvykti is an individualized cellular product prepared from the patient's own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient. Idecabtagene...

The FDA has approved two new long-acting injectable formulations of second-generation antipsychotics for treatment of schizophrenia: aripiprazole lauroxil (Aristada – Alkermes), which is given once every 4-6 weeks, and paliperidone palmitate (Invega Trinza – Janssen), which is given once every 3 months. Once-monthly injectable formulations of aripiprazole (Abilify Maintena) and paliperidone palmitate (Invega Sustenna) were approved earlier.

The FDA has approved Onzetra Xsail (Avanir), a nasal powder formulation of sumatriptan, for acute treatment of migraine in adults. Nasal spray formulations of sumatriptan (Imitrex) and zolmitriptan (Zomig) have been available for many years.

Nabilone (Cesamet - Lilly), a synthetic cannabinoid chemically related to tetrahydrocannabinol (THC), the main active ingredient in marijuana, was recently marketed in the USA for oral treatment of nausea and vomiting associated with cancer chemotherapy. Oral THC itself, known generically as dronabinol (Marinol), is also commercially available as an antiemetic for cancer patients (Medical Letter, 27:97, 1985). Other drugs used for this purpose include metoclopramide (Reglan - Medical Letter, 24:67, 1982), prochlorperazine (Compazine; and others), haloperidol (Haldol; and others), and...

A recent supplement to the Journal of Clinical Psychiatry, titled "The Expert Consensus Guideline Series: Optimizing Pharmacologic Treatment of Psychotic Disorders," concluded that most experts endorsed use of second-generation (atypical) antipsychotics rather than first-generation drugs, with risperidone (Risperdal - Janssen) the top choice for first episodes, multiple episodes or switches from another drug (JM Kane et al, J Clin Psychiatry 2003; 64 suppl 12:5). The supplement was sponsored by Janssen.

Tetrabenazine (Xenazine - Ovation Pharmaceuticals), an old drug first synthesized 50 years ago for treatment of schizophrenia, was recently approved by the FDA for the treatment of chorea associated with Huntington's disease. It has been available in other countries for decades.