Boston, MA 02/04/2014 (wallstreetpr) – Has Furiex Pharmaceuticals Inc (NASDAQ:FURX) finally found a winning drug? When every big or small biopharmaceutical is engaged in the pursuit of oncology treatments, this small biopharmaceutical company is trying to solve the problems affecting approximately 28 million people in U.S. and other major European markets.
The Disease:
Though the disease is prevalent across the globe, it is rarely discussed by the patients themselves, in fact, they may not be aware that they suffer from it. The disease is known as Irritable Bowel Syndrome commonly referred to as IBS and Furiex Pharmaceuticals Inc (NASDAQ:FURX) is developing a line of treatment specifically aimed at IBS-d, a functional bowel disorder that is characterized by frequent diarrhea and chronic abdominal pain. The other thing going for the company is that there are few options available for treatment as we still have to understand the causes. The disease however has a substantial medical and social costs associated with it and it affects the quality of life of the patient. Furiex collaborates with other pharmaceutical and biotechnology companies to speed up the drug development programs. The company aims at developing innovative treatments at a faster rate at a lower cost. It also tries to reduce the time to market.
The Trial Results:
Furiex has developed a novel agent which treats the diarrhea and pain symptoms associated with IBS-d without the side effects of constipation. The drug, Eluxadoline, has been granted Fast Track Status by the FDA. The company announced the results of two critical Phase 3 clinical trials aimed at evaluating both the efficacy and safety of the drug. The top-line results indicate that the drug meets the end-points agreed between the company with the U.S. FDA as well as the European Medicines Agency (EMA). The treatment resulted in improvements in stool consistency as well as abdominal pain. There were minimal side effects observed during the clinical trials.
The drug has been extensively tested. A total of nine Phase 1 trials were completed, followed by a Phase 2 trial involving 800 patients. The current Phase 3 trials involved about 2500 patients and were a combination of two trials, one aimed at the US FDA and other at EMA. Furiex Pharmaceuticals Inc (NASDAQ:FURX) has already completed all toxicology studies and has also undertaken studies related to production. It is confident that an NDA can be submitted by the end of the second quarter of 2014.
