Great Lakes Clinical Trials and our Medical Director, Jeffrey Ross MD, are pleased to announce that our research team contributed to the clinical data reviewed by the Food and Drug Administration (FDA) or the approval of Vyleesi™ (bremelanotide injection) for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).
Per their June 21, 2019 press release, “Palatin Technologies, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval of AMAG Pharmaceuticals, Inc.'s New Drug Application (NDA) for Vyleesi™ (bremelanotide injection), a melanocortin receptor agonist developed by Palatin indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).”
“We are proud to have participated in this important research program,” commented Steve Satek, President of Great Lakes Clinical Trials. “It is important to acknowledge the significant contribution that our Great Lakes Clinical Trials study participants provided, in order to move this novel medication to market and offer a treatment for this under-recognized medical condition.”
Hypoactive Sexual Desire Disorder (HSDD) is the most common type of female sexual dysfunction in the U.S. The condition is characterized by low sexual desire and marked distress which are not attributable to existing medical, pharmacologic, psychiatric, or relationship issues. Approximately 6 million pre-menopausal women meet the diagnosis criteria for acquired, generalized HSDD. Patient awareness and understanding of the condition remains low, and few women currently seek or receive treatment. Recent industry-sponsored market research indicates that up to 95 percent of premenopausal women suffering from HSDD are unaware that it is a treatable medical condition.
To view the Palatin Technologies press release in its entirety, click here.