Sinclair Pharma plc (SPH.L), the specialty pharmaceutical company announced that Sebclair, its product for seborrheic dermatitis, has been cleared for marketing by the US Food and Drug Administration (FDA). Sebclair will be sold on prescription in the US.
SD is a common and visible condition characterized by flaky, red skin. It is most common in men and may be present in 5 per cent of the adult population i. It usually affects areas of the skin with high oil production, such as the nose, eyebrows, ears and chest.
Sebclair is the first topical non-steroidal product cleared for marketing in the US through 510k registration, that can also specifically claim reduction of erythema (redness) as a symptom of seborrheic dermatitis (SD). This is significant because the appearance of SD can make patients self-conscious and distressed and leads to them seeking treatment, when the reduction of redness and flaking is an important goal. SD is often treated with topical corticos teroids, however there are reservations about the use of steroids on the face. As SD is particularly common on the face, there is a specific
need for a product that is steroid-free, a Sinclair Pharma release stated.
Earlier this year, Sinclair announced the results of a US and European, randomized, double-blind study that compared Sebclair™ with an emollient cream. In this study, after 28 days, 68 per cent of patients receiving Sebclair were 'clear' or 'almost clear' of SD of the face, compared to 11 per cent of patients using the emollient cream.
Professor Stefano Veraldi of the Institute of Dermatological Sciences, Milan, Italy, the lead investigator of that trial commented: "Our study showed that Sebclair is effective in reducing the appearance and symptoms of seborrheic dermatitis. The condition is very visible and often affects the self esteem of patients and we welcome a steroid-free treatment for seborrheic dermatitis Sinclair's marketing partner for Sebclair in the US is Chester Valley Pharmaceuticals (CVP). CVP is already achieving growing sales for Atopiclair, Sinclair's atopic dermatitis product. Atopiclair, like Sebclair, is classified by the FDA as a medical device, cleared for marketing by 510(k). In Europe, Sebclair is approved as a Class 2a medical device and has already been launched in Italy by Sinclair's own sales team.
The seborrheic dermatitis market is worth an estimated US$272 million in the US and a further US$150.9 million combining the UK, French, German and Japanese marketsii.
Bob Moccia, CEO of CVP, said: "With this registration, we now look forward to launching Sebclair to the US dermatology community. Sebclair meets a clear market need, and based on the compelling results of the pivotal clinical study we anticipate that it will be welcomed by physicians and their patients."
Dr Michael Flynn, CEO of Sinclair Pharma, commented: "The registration of Sebclair in the US is a very important step towards establishing a steroid free product range to effectively treat skin conditions which are at present often treated with corticosteroids.
The proven effectiveness and registration of Sebclair provides an alternative, and importantly steroid-free, first line treatment in the US for this distressing condition. As with our products Atopiclair and Decapinol we are very pleased to have achieved another first in class registration in the US .
Sebclair is already sold by our own sales force in Italy and we expect further sales boosts as it is launched in other EU countries and the US during the next 12 months."
Sinclair also announces that both Xclair, its product for radiation dermatitis, and SST, its product for xerostomia (dry mouth), have received regulatory approval in Canada.