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FDA Rejects Two Forms of Experimental Heart Drug Yosprala (Aspirin/Omeprazole)

Agency cites manufacturing deficiencies

The FDA has issued a second complete response letter (CRL) for two versions of the experimental heart drug Yosprala (aspirin/omeprazole), citing deficiencies in the manufacturing plant of a supplier of an active ingredient. The FDA issues CRLs when questions remain that preclude the approval of a new drug application in its current form.

In its second CRL for Yosprala, the FDA used identical wording to that of its first letter, which stated that during an inspection of the foreign manufacturing facility of an active-ingredient supplier in April 2014, an FDA field investigator conveyed deficiencies to the representative of the facility. Satisfactory resolution of these deficiencies is required before the new drug application for Yosprala can be approved. No clinical or safety deficiencies were noted with respect to either Yosprala 81/40 or Yosprala 325/40 (aspirin/omeprazole delayed-release tablets), and no other deficiencies were noted in the CRL. Final agreement on the draft product labeling is also pending.

The supplier responded to the FDA’s concerns in May 2014 with a plan of action to correct all of the deficiencies noted. Since that time, the supplier has provided updates to the FDA on their progress on the action plan.

According to the product’s developer (Pozen Inc.), several investigational integrated aspirin therapies are being developed in the Yosprala portfolio with the goal of reducing gastrointestinal (GI) ulcers and other GI complications compared with taking enteric-coated or plain aspirin alone.

The first candidates are Yosprala 81/40, containing 81 mg of aspirin, and Yosprala 325/40, containing 325 mg of aspirin. Both products are coordinated-delivery tablets combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core. The product is intended for oral administration once a day.

Pozen is seeking FDA approval for the use of Yosprala 81/40 and Yosprala 325/40 in the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. Specifically, proposed indications include the use of the product in patients who require aspirin 1) to reduce the combined risk of death and nonfatal stroke in patients who have experienced ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli; 2) to reduce the combined risk of death and nonfatal myocardial infarction (MI) in patients with a previous MI or unstable angina pectoris; 3) to reduce the combined risk of MI and sudden death in patients with chronic stable angina pectoris; 4) to treat patients who have undergone revascularization procedures, such as coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA), when there is a pre-existing condition for which aspirin is already indicated; and 5) to decrease the risk of developing gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers.

Controlled studies with Yosprala 81/40 and Yosprala 325/40 did not extend beyond 6 months.

Source: Pozen Inc.; December 17, 2014.


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