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news.Cip-Isotretinoin, indicated for the treatment of severe, nodular acne
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Cipher Pharmaceuticals (Cipher) has enrolled first patient in its phase III safety study of Cip-Isotretinoin, the company’s patented formulation of isotretinoin, used in the treatment of severe, nodular acne.
The study is randomised, double-blinded trial comparing the safety profile of Cip-Isotretinoin to an FDA-approved, commercially available isotretinoin product.
Reportedly, the study will be conducted at 50 sites in the US and Canada, and is expected to enroll more than 800 patients over an 18-month period. The study is being conducted under a Special Protocol Assessment (SPA) that was granted by FDA.
The company said that in the clinical studies Cip-Isotretinoin has demonstrated significantly more consistent absorption under variable dietary conditions, compared to existing isotretinoin products on the market.
The company claims to achieve optimal absorption, current isotretinoin formulations are prescribed to be taken with meals. Cip-Isotretinoin uses Lidose drug delivery system, which delivers super-bioavailability for relatively water-insoluble compounds.
As previously disclosed, Ranbaxy Pharmaceuticals is reimbursing Cipher for all costs associated with the clinical studies required to obtain FDA approval, up to a predetermined cap. Any additional development costs associated with initial FDA approval will be shared equally.
However, Cipher is responsible for all product development activities, including management of the clinical studies required by the FDA to secure NDA approval.
Larry Andrews, president and CEO of Cipher, said: “We are pleased to reach this clinical development milestone for our novel isotretinoin formulation. Isotretinoin is the effective treatment for severe, nodular acne. We believe this product’s attributes, particularly the more consistent absorption profile, would provide a significant advancement in the treatment of severe acne. We look forward to working closely with our US marketing partner, Ranbaxy, as we advance this final clinical study and prepare for the commercialisation of the product in the $700m US isotretinoin market.”