FDA accepts to review POZEN’s NDA refiling for PA8140/PA32540 tablets

FDA also said that the NDA would be treated as a Class 2 resubmission; hence, the new user fee goal date is 30 December 2014.

In April 2014, the company received a Complete Response Letter (CRL), which noted the issues raised during an audit of the manufacturing facility that produces an active ingredient used in the creation of the products were the only deficiencies.

According to the company, if such inspection deficiencies are not satisfactorily addressed by the new user fee goal date, the FDA could issue another CRL.

The company has also agreed substantively to the FDA’s most recent draft product labeling.

The PA product platform is a portfolio of investigational integrated aspirin therapies created by the company.

Products in the PA portfolio are being developed with the goal of reducing GI ulcers and other GI complications compared to taking enteric-coated or plain aspirin alone.

The first candidates are PA8140 that contains 81mg of aspirin, and PA32540, which contains 325mg of aspirin.

The company said that both products are a coordinated-delivery tablet combining immediate-release omeprazole (40mg), a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core.

The new patented product is intended for oral administration once a day and an indication is being sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.

Image: First candidates in POZEN’s PA portfolio are PA8140 that contains 81mg of aspirin, and PA32540, which contains 325mg of aspirin. Photo: courtesy of Michelle Meiklejohn/ freedigitalphotos.net