PHILADELPHIA, May 5 /PRNewswire/ -- An investigational treatment for endometriosis, FP1096, reduced the painful symptoms of endometriosis in trial subjects with minimal side effects, according to Phase II clinical study results presented this week at the 52nd Annual Clinical Meeting of The American College of Obstetricians and Gynecologists (ACOG). FP1096 is being developed by FemmePharma, a late stage specialty pharmaceutical company dedicated to developing drugs for diseases and disorders disproportionately affecting women. Drs. W. Paul Dmowski and Tom Janicki, investigators in the study and members of FemmePharma's Scientific Advisory Board, co-authored the abstract that was published in the April 2004 edition of Obstetrics and Gynecology.
"FemmePharma welcomed the opportunity to review our Phase II study results with the ACOG community. We viewed it as a venue to share the study's outcomes and to create dialogue for the future. FemmePharma is looking forward to continuing the clinical development of FP1096 and ultimately bringing it to the OB/GYN market," said the Company's President and CEO, Gerianne Tringali DiPiano.
This was a multicenter, prospective, open-label study conducted in the U.S. Approximately 30 subjects were recruited from four centers across the U.S.; each of these subjects had endometriosis which had been surgically diagnosed within three years of enrollment. Subjects were screened to assess their suitability and to ensure that they had moderate-to-severe endometriosis. Severities of symptoms associated with endometriosis (i.e., dysmenorrhea, dyspareunia, pelvic pain, pelvic tenderness, induration) were assessed using the Biberoglu and Behrman Symptom Score (BBSS). Change from baseline to the end of treatment in BBSS was the primary efficacy endpoint. Additionally, secondary efficacy endpoints, including a pain assessment questionnaire, a quality of life measure and a daily diary assessment, were also collected.
The primary efficacy endpoint demonstrated a statistically significant decrease indicating the subjects had a diminishment in the symptoms associated with endometriosis. The secondary efficacy endpoints supported and corroborated the observation that FP1096 reduced the pain associated with endometriosis.
Endometriosis is the leading cause of infertility among reproductive age women and the most common non-malignant gynecological disorder in the U.S. The disease affects 89 million women worldwide. Traditional treatments include oral medications or surgery. Today's approved treatments for endometriosis can carry significant systemic side effects - either menopausal (bone loss, mood swings, hot flashes) or androgenic (acne, facial hair growth, deepening of voice and reduction of breast size).
FP1096 is an investigational drug delivered intravaginally directly to the targeted region of the disease. Through local delivery of FP1096, FemmePharma hopes to reduce or avoid the unwanted systemic side effects.
About FemmePharma, Inc.
FemmePharma was founded by Gerianne Tringali DiPiano in 1996 to target needs within the estimated $70 billion women's healthcare pharmaceutical market. The company is in a Phase III trial for FP1096, a new investigational treatment for endometriosis, and is preparing for its Phase II trial for its drug to treat female urinary incontinence.
FemmePharma is devoted to developing safe and effective drugs that minimize or eliminate unpleasant side effects associated with many medications by designing them in a manner that is specifically suited to a woman's physiology, with an eye toward the changing needs of women throughout their lives. The company has a number of drugs in development based on its proprietary technologies, including a new therapeutic option for fibrocystic breast disease. For more information about FemmePharma, please visit its website at http://www.femmepharmainc.com/.