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PD0609 TxUpdate_Pipeline 6/4/09 10:26 AM Page 56 Therapeutics Update In The Pipeline Product News There has been recent interest in the use of beta-blockers for the treatment of severe infantile hemangioma. Now Pierre Fabre Laboratories has announced the launch of a set of clinical trials for a pediatric beta-blocker with the intention of obtaining NDA-approval (New Drug Application) both for Europe and the USA. New Laser on the Market. High speed hair reduction may now be possible, since Lumenis has introduced the LightSheer Duet Diode Laser System. According to the company, the LightSheer Duet cuts hair removal treatment times by up to 75 percent and improves patient comfort. The system features two hair removal systems on one platform, enabling physicians to optimize permanent hair reduction anywhere on the body, the company says. The platform also include the LightSheer ET system, which Lumenis says is ideal for smaller or bony anatomic areas. Beta-blockers were first considered for the treatment of hemangiomas by the University of Bordeaux’s Dr. Christine Leaute-Labreze and colleagues. In a 2008 letter to the editor in the New England Journal of Medicine(358:2649-2651) Dr. Leaute-Labreze referenced a small study in which the beta blocker propranolol effectively treated hemangiomas in 11 patients. Of the new beta blocker developed by Pierre Fabre, Dr. Leaute-Labreze explains that it has been effective in several hundred children throughout the world. Nevertheless, she notes, rigorous clinical trials are required to ascertain the efficacy and tolerance of this new therapeutic strategy. 56 "This is a major discovery that will bring true therapeutic advance to patients affected by this highly apparent disease, which can be very severe and can have a strong impact on their quality of life and that of their parents,” says Jacques Fabre, General Manager of Pierre Fabre Dermocosmetique in a statement. ■ Practical Dermatology June 2009 PD0609 TxUpdate_Pipeline 6/4/09 10:26 AM Page 57 Therapeutics Update OTC Combination. A new non-prescription option for hyperpigmentation is now available. Neutraderm recently unveiled HQRA OTC formulation, a combination of Hydroquinone, Transretinol, and Hydrocortisone Acetate they say was designed to inhibit the production of excessive skin pigment and melanin formation. According to the company, the physician-dispensed product was specifically formulated to replicate similar prescription products and is ideal for use in conjunction with in-office procedures. Meet Again. Reintroduced to the market, Clinac BPO 7% Gel is once again available for treatment of mild to moderate acne. The vehicle contains oil-absorbing Acrysorb technology, which Ferndale says virtually “drinks up” excess sebum. The prescription formulation of BPO 7% is oil-free, alcohol-free and fragrancefree. Ferndale is offering patient mail-in rebates for 50 percent off out-ofpocket costs or co-pays up to $30. A Close Shave. For patients seeking a close shave without bumps and burns, consider dispensing Glytone’s Serious Shave Cream, a glycolic acid-containing lotion (9.8 percent concentration) that provides protection and lubrication during shaving. Glytone Serious Shave Cream delivers a clean, close shave and also softens and conditions the skin, helping to reduce razor burns, the company says. NeXTRAC. Patients undergoing treatment with the XTRAC Laser may be interested in the XTRAC Laser Post-Procedure Kit, a three-product system from PhotoMedex that the company says speeds healing and provides comfort and protection to skin post-treatment. Included in the kit is the Complex Cu3 Intensive Tissue Repair Crème, Complex Cu3 Post-Laser Lotion, and Ti-Silc Sheer SPF45. Products feature GHK Copper Peptide Complex, which the company says positively impacts collagen deposition, tensile strength, and anglogenesis to enhance healing for patients treated for psoriasis/vitiligo, cosmetic surgery, and hair transplant procedures. ■ June 2009 FDAACTIONS Simponi Cleared. Centocor’s golimumab (Simponi) got the FDA nod for the treatment of chronic immune types of arthritis. For more on this new anti-TNF agent, see “Recent Developments,” p. 6 Dysport Approved. The FDA approved Ipsen’s Dysport, to be marketed for cosmetic indications by Medicis, for treatment of glabellar lines. For more on this new abobotulinum toxin A therapy, see coverage in this issue. Boxed Warning for Botulinum Toxin. In follow-up to an ongoing safety review, FDA announced that makers of botulinum toxin treatments are now required to add a boxed warning about adverse events that may occur if the effects of the toxin spread beyond the injection site. These products include Allergan's Botox (botulinum toxin type A), Solstice Neurosciences' Myobloc (botulinum toxin type B), and Medicis' and Ipsen's Dysport (abobotulinumtoxin A). The agency reviewed reports of adverse events dating back to 1989, according to Ellis Unger, acting deputy director at the FDA, and found evidence that the toxins may travel beyond the injection site to weaken or paralyze muscles used for breathing and swallowing. In adults, most reports of distant spread of botulinum toxin occurred in patients who received Botox or Myobloc for unapproved use in spasticity, or for approved use in cervical dystonia. The FDA said that it could not attribute several deaths in adults to botulinum toxin because patients also had preexisting conditions. The agency noted that it has identified "no definitive serious adverse-event reports of distant spread of toxin effect associated with dermatologic use of Botox" at approved doses. ■ Practical Dermatology 57