Name/CompanyApproval Dates and Comments

Delayed-release prednisone tablets

Horizon Pharma, Inc.

The US FDA approved a delayed-release corticosteroid in July 2012 indicated as an anti-inflammatory or immunosuppressive agent to treat a wide spectrum of diseases including rheumatoid arthritis, psoriatic arthritis, polymyalgia rheumatica, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease (COPD). The delayedrelease tablet formulation will be available in 1 mg, 2 mg, and 5 mg strengths.

Imiquimod 3.75% cream

Meda AB

The European Commission (EC) granted marketing authorization to this immune response modifier in August 2012 for the topical treatment of actinic keratosis. This approval is valid in all European Union countries.

Lidocaine topical 5% patch

Watson Pharmaceuticals

The FDA has approved an abbreviated new drug application (ANDA) in August 2012 for lidocaine topical 5% patch. Treatment is indicated for the relief of pain associated with post herpetic neuralgia (innovator brand Lidoderm®, Endo Health Solutions Inc.).

Clobetasol propionate 0.05% shampoo

Perrigo Company

The FDA approved an ANDA in August 2012 for clobetasol propionate shampoo 0.05%, which is indicated for the treatment of moderate to severe scalp psoriasis (innovator brand Clobex® Shampoo, Galderma).

Drug News

Apremilast (CC-10004), an orally administered phosphodiesterase-4 inhibitor, has been under active investigation for the treatment of psoriasis, psoriatic arthritis (PsA) and other chronic inflammatory diseases. Apremilast appears to dose dependently inhibit tumor necrosis factor-alpha (TNF-α) production. In September 2012, a press release by Celgene International reported that three pivotal phase III, randomized, placebo-controlled studies (PALACE-1, 2 & 3) including approximately 1,500 patients, achieved statistical significance and clinically meaningful improvements for the primary endpoint, as well as other measures of signs and symptoms and physical function for patients receiving apremilast 20 mg or 30 mg twice-daily. Among PsA patients, statistically significant response of ACR20 (a measure of success in reducing symptoms) was shown at week 16, which was maintained through week 24. Studies are ongoing through to week 52. Based on the combined PALACE-1, 2 & 3 studies for PsA, a new drug application (NDA) is expected to be filed with the FDA in the first quarter of 2013. A combined marketing authorization application (MAA) submission for PsA and moderate to severe psoriasis in Europe is also planned for the second half of 2013.

In September 2012, the FDA issued a warning to consumers regarding the potential for serious skin injuries resulting from the use of over-the-counter pain relieving products (including creams, lotions, ointments, and patches) applied to the skin to alleviate mild muscle and joint pain. Although reported cases are rare, the injuries ranged from mild to severe chemical burns caused by the active ingredients menthol, methyl salicylate, or capsaicin (brand-names include Bengay®, Capzasin®, Flexall®, Icy Hot®, and Mentholatum®). Adverse effects included burns at the application site after single administration, with severe burning or blistering developing within 24 hours, and some cases requiring hospitalization. A higher incidence of severe burns was associated with the use of a menthol or menthol/methyl salicylate combination product. Products containing higher concentrations of menthol and methyl salicylate (>3% menthol or 10% methyl salicylate) posed the greatest risk and few of the cases involved capsaicin.
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