|Name/Company||Approval Dates and Comments|
The US FDA approved gabapentin extended release tablets in January 2011 for the once-daily treatment of post-herpetic neuralgia (PHN), the pain following herpes zoster infection (shingles). Treatment is to be titrated over a 2-week period to an 1800 mg once-daily dose. The tablet swells in gastric fluid and gradually releases gabapentin. This formulation is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles that affect the frequency of administration. Furthermore, the FDA has granted GRALISE™ Orphan Drug status.
The US FDA approved a new skin care gel in February 2011 for the management of burning, itching, and pain associated with various types of dermatoses, including atopic dermatitis and radiation dermatitis. The product is approved as a medical device and granted 510(k) clearance for marketing. This prescription product is intended for use under the supervision of a healthcare professional. In addition, the gel relieves the pain of first- and second-degree burns and maintains a moist wound and skin environment to help treat dry and waxy skin. The hydrogel is a shelf-stable hypochlorous acid formulation based on the proprietary Microcyn® technology platform.
The European Commission (European Medicines Agency) approved this novel injectable treatment in February 2011 for Dupuytren’s contracture in adults with a palpable cord. It was US FDA approved in 2010 under the trade name of XIAFLEX®.
A recently published study* in the New England Journal of Medicine reported that the human papilloma virus (HPV) quadrivalent (types 6, 11, 16 and 18) recombinant vaccine (Gardasil®) is as effective at preventing HPV infection and genital warts in men as it is in women. The study enrolled 4065 healthy boys and men (aged 16 to 26 years) from 18 countries in a randomized, placebo-controlled, double-blind trial and found that HPV vaccination was 90% effective in protecting against HPV and genital warts. Although the reduction in precancerous lesions may reduce the rates of penile and anal cancers in males, their incidences are significantly lower than cervical cancer. This investigation does not address the cancer risk in the specific age-gender group studied.
Both of the HPV vaccines (Cervarix™ and Gardasil®) are recommended for females aged 9 through 26 for the prevention of cervical cancers caused by HPV types 16 and 18 (high risk types), which cause most cervical cancers. These vaccines are now on the US Centers for Disease Control and Prevention’s (CDC) routine childhood vaccination schedule for girls starting at age 9. Only one of the vaccines (Gardasil®) also protects against HPV types 6 and 11, which cause most genital warts in females and males. The quadrivalent vaccine is recommended for optional use in boys and men. Gardasil® was approved for use in males 9 through 26 years of age in 2009 by the US FDA, however, the CDC’s advisory panel voted against routine use of the vaccine in boys and men.
*Giuliano AR, Palefsky JM, Goldstone S, et al. Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males. N Engl J Med 364(5):401-11 (2011 Feb 3).