Sagene Pharmaceuticals, Inc., a biopharmaceutical company focused on developing combinations of FDA-approved drugs to treat diseases associated with aging, has completed a pre-IND (Investigational New Drug) meeting with the Division of Reproductive and Urologic Products of the FDA to discuss the development plan for SPI-1972, a dual-action combination treatment for erectile dysfunction. The FDA addressed the Company's questions and provided guidance on the NDA requirements for the SPI-1972 development program. The FDA found the filing of an IND for SPI-1972 acceptable under the 505(b)(2) regulations as a combination product in which the active ingredients have been previously approved individually. The 505(b)(2) regulations provide an accelerated pathway for drug approval.
"The successful completion of our Pre-IND meeting is a step in the right direction towards the filing of the IND for our Erectile Dysfunction Program," said Sagene Chief Executive Officer and Founder Tom Thomas, MD, Ph.D. "The FDA's guidance has improved our development program and the acceptance of 505(b)2 application requirements means SPI-1972 could reach patients significantly faster."
SPI-1972 is an oral combination product consisting of selegiline, an FDA-approved MAO-B inhibitor, and a PDE-5 inhibitor, such as Viagra®, Cialis® or Levitra®. This patented combination is the only erectile dysfunction drug with dual actions targeting CNS and vascular tissue, increasing dopamine neurotransmission in the brain and enhancing the levels of NO (nitric oxide) and cGMP in target tissue. In animal studies, Sagene found that selegiline enhances the action and acts synergistically with PDE-5 inhibitors in healthy and diabetic models.
"Based upon our preclinical data, and the overall safety profile of both agents, we are excited by the prospects for this program and the potential to treat a large group of patients that do not adequately respond to current treatments for erectile dysfunction," commented Albert J. Azzaro, Ph.D., Acting Vice President of Research and Development for Sagene.
Source: Sagene Pharmaceuticals, Inc.