* Says drug meets non-inferiority efficacy margins
* Company to submit NDA in Q4
* Expects six month review period (Follows alerts)
June 7 (Reuters) - Cipher Pharmaceuticals said a late-stage trial showed that its experimental drug to treat a severe form of acne was as safe and effective as currently available treatment.
The non-inferiority trial, which included 925 patients suffering with nodular acne, was comparing the safety profile of the company’s patented formulation of CIP-Isotretinoin with commercially available isotretinoin product, the company said.
The company is banking on the superior absorption profile of its formulation compared with existing isotretinoin products. To achieve optimal absorption, Cipher delivers its formulation using its drug delivery system Lidose, while current formulations are prescribed to be taken with meals.
The drug also met the non-inferiority efficacy margins set for the late-stage trial.
The company said it will use these results along with previously submitted data to submit a revised new drug application to U.S. health regulators in the fourth quarter.
It expects the U.S. Food and Drug Administration to issue a six month review date.
Shares of the company closed at C$1.10 on Monday on the Toronto Stock Exchange. (Reporting by Anand Basu in Bangalore; Editing by Don Sebastian)