GREENWOOD VILLAGE, Colo., Dec. 2, 2013 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced receipt of FDA correspondence confirming the acceptance of The Spring Study as pivotal and providing guidance for the design of the second and final pivotal trial of Ampion™ for the treatment of osteoarthritis of the knee (OAK).
Dr. Vaughan Clift, Ampio's Chief Regulatory Officer, noted the letter summarized the FDA's conclusions after reviewing the complete clinical data set provided by Ampio following their October 29 th pre-BLA meeting. The FDA letter includes the following statements:
- " Upon review of the dataset received on November 5, 2013, FDA concludes that study AP-003-A can be considered as one of two "pivotal trials" required in support of a BLA."
- "This recommendation is based on the fact that study AP-003-A was adequate (n=329) and well controlled (normal saline), the trial conduct was acceptable and the study met its primary endpoint (change in WOMAC score at 12 weeks)."
- "The strength of the evidence is robust"
- "FDA recommends that Ampio conduct an adequately powered study to confirm the effect size of AP-003-A and design the study to obtain information on the duration of action and repeat dosing."
- "The study to evaluate safety and efficacy of repeat dosing may be conducted post market approval."
Dr. Clift continued, "Our interactions with the FDA have been helpful at every step of this process and we are very grateful for their guidance. The final pivotal trial will confirm the efficacy and safety of the 4 ml injection in approximately five hundred (500) patients with a follow-up of no less than twenty (20) weeks in order to better understand the duration of action. This trial is planned to begin in early January 2014 with an additional six (6) clinical sites added to the nine (9) sites utilized in the SPRING study. Submission of the BLA, the documents used for approval, could then occur in the 3 rd quarter of 2014."Michael Macaluso, Chairman and CEO of Ampio commented "We are all very proud of the excellent work of our clinical team, led by Dr. David Bar-Or, our Chief Science Officer, and the inventor of Ampion ™, and Dr. Clift, that culminated in this encouraging FDA guidance." "Most important, greater improvement in pain relief was reported in patients with the most severe disease (Grades III and IV), which means we are now closer to the day when we may be able to significantly reduce the suffering and improve the quality of life for the millions of patients so greatly afflicted."