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.

The FDA has approved a new oral solution of the calcium channel blocker nimodipine (Nymalize – Arbor) to reduce the severity of neurological deficits associated with vasospasm after subarachnoid hemorrhage from a ruptured intracranial aneurysm. An older formulation of nimodipine has been available for such use for many years.1Since 1988, nimodipine has been available only in liquid-filled gel capsules (Nimotop, and generics) that a conscious patient could swallow intact. For unconscious patients, the package insert included instructions for use of a needle and syringe to aspirate the liquid...

In the CLINICAL STUDIES - Other Cancers paragraph (Med Lett Drugs Ther 2007; 49:35), the dosage in the first line should be 2.5 mg/kg, not 25 mg/kg.

The FDA has required the manufacturer of eszopiclone (Lunesta – Sunovion), a benzodiazepine receptor agonist approved for the treatment of insomnia, to lower the current recommended starting dose to 1 mg for both men and women because a new study found that an evening dose of 3 mg can impair driving skills, memory, and coordination for more than 11 hours.1 Eszopiclone’s half-life is longer than that of any other drug in its class, which includes zolpidem (Ambien, and generics) and zaleplon (Sonata, and generics).All benzodiazepine receptor agonists may impair performance the next morning,...

Paclitaxel (Taxol - Bristol-Myers Squibb) is now available in the USA for treatment of metastatic ovarian cancer refractory to other drugs. The new drug is a natural product extracted in small amounts from the inner bark of the Western yew tree found mainly in the Pacific northwest (Taxus brevifolia). Efforts to synthesize the drug have been unsuccessful to date, but a semi-synthetic product (taxotere) prepared from the needles of European yews has shown some promise (R Pazdur et al, J Natl Cancer Inst, 89:1781, 1992), and a fungus (Taxomyces andreanae) growing on the Pacific yew was...

(Med Lett Drugs Ther 2007; 49:55) The second sentence in the article ("The FDA does not require proof of effectiveness for approval of devices with minimal potential for harm, such as this one.") should have been omitted. It would apply to a Class I device, but the FDA has classified Resperate as a Class II device.

The Medical Letter article (Med Lett Drugs Ther 2007; 49:71) on Low-Dose Transdermal Estrogens said that Elestrin has been marketed in Europe since 1976. Actually it is EstroGel (Ascend Therapeutics), a similar product, that has been available in Europe since 1976.

Development of abuse-deterrent opioid products, including reformulation of existing products, has become a priority for drug manufacturers and public health advocates. Since our last article on this subject, several new abuse-deterrent opioid formulations have been approved by the FDA, including an oxycodone tablet formulation (Roxybond – Inspirion) that is the first immediate-release opioid product FDA-approved to include claims of abuse deterrence in its labeling. No opioid formulation prevents consumption of a large number of intact dosage units, the most common method of...

A 0.05% ophthalmic solution of levocabastine hydrochloride (Livostin - Iolab), a histamine H 1 -receptor antagonist, has been approved by the US Food and Drug Administration for treatment of seasonal allergic conjunctivitis. The new drug is a cyclohexylpiperidine derivative with no structural relationship to any other antihistamine.

Previously approved by the FDA for treatment of depression, general anxiety disorder, diabetic peripheral neuropathic pain and fibromyalgia, duloxetine (Cymbalta – Lilly) has now also been approved for treatment of chronic musculoskeletal pain.