Sinclair's Sebclair gets FDA OK for SD

UK-based specialty drugmaker Sinclair Pharma says that Sebclair, its treatment for seborrheic dermatitis has been approved by the US Food and Drug Administration. The firm explained that the product, which will be sold on prescription in the USA, is the first topical non-steroidal drug cleared under the 510k registration.

Earlier this year, Sinclair published the results of US and European trials of the agent which demonstrated that it was superior to an emollient cream. The data showed that 68% of patients treated with the product were "clear" or "almost clear" of erythema (the redness associated with the condition) after 28 days of treatment, compared with only 11% of those who used the emollient cream.

Sinclair's US marketing partner Chester Valley Pharmaceuticals, which currently sells the UK firm's atopic dermatitis product Atopiclair, will also carry out marketing of SebClair, targeting the estimated $272.0 million per year SD market.