Buprenorphine Transdermal System (Butrans) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid analgesia. It will be available in early 2011 at 5-µg/hour, 10-µg/hour, and 20-µg/hour dosage strengths as a Schedule III controlled substance. Each patch releases the drug continuously over seven days.1 A dose of 20 µg/hour should not be exceeded due to the risk of QTc interval prolongation.2 Other warnings and contraindications apply.
Explore This IssueSeptember 2010
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CIP-Tramadol ER, an extended-release tramadol product, has been FDA-approved for treating adults with moderate to moderately severe chronic pain.3 The product is a capsule comprising an immediate-release tablet and sustained-release beads. It can be taken without food.
Denosumab injection (Prolia) has been FDA-approved for postmenopausal women at risk for fractures.4 Postmenopausal osteoporosis studies were completed in 7,000 women and evaluated both hip and vertebral fractures. Denosumab is administered once every six months by injection to increase bone mass and bone strength. Common side effects reported in clinical trials included back pain, hypercholesterolemia, and bladder infections. Denosumab will cost approximately $825 per injection and will be competitively priced with orally administered osteoporosis treatments.
Methoxsalen 10 mg capsules (Oxsoralen) are available again for treating severe psoriasis.5 These capsules are available on a limited supply basis following a product shortage due to an unanticipated change in the active ingredient supplier.
Tramadol orally disintegrating tablets (Rybix ODT) have been FDA approved to treat moderate to moderately severe pain in patients 17 years of age and older.6 No studies have been completed to indicate whether tramadol ODT has a faster onset of action than orally administered immediate release tramadol tablets. The tablets contain phenylalanine.
Valacyclovir hydrochloride tablets in both 500-mg and 1,000-mg strengths are now available generically. Valacyclovir is approved by the FDA to treat cold sores (herpes labialis), initial and recurrent episodes of genital herpes in immunocompetent adults, chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in HIV-infected adults, reduction of transmission of genital herpes in immunocompetent adults, and treatment of herpes zoster in immunocompetent adults.7
Acetaminophen injection (Ofirmev) has received a new Prescription Drug User Fee Act (PDUFA) action date of November 4, 2010.8 The manufacturer (Cadence Pharmaceuticals, Inc.) received a complete response letter in February from the FDA, citing deficiencies in the production facilities. No safety issues, efficacy issues, or requests for additional clinical trials are needed prior to approval. Cadence met with the FDA in April to discuss these deficiencies, and they resubmitted their New Drug Application (NDA) in May. Intravenous acetaminophen is approved in 80 countries worldwide, including major markets in Europe.