You are here
Endometriosis Treatment FP1096 Reduced Symptoms in Phase II Trial
This was a multicenter, prospective, open-label study conducted in the United States. Approximately 30 subjects were recruited from 4 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.
Dr. Tom Janicki, a practitioner at Green Road Obstetrics and Gynecology and a Scientific Advisory Board member for FemmePharma, commented, "FP1096 appears to have been well tolerated by the patients participating in the study and results of this trial indicate that the pain associated with the disease was relieved. Development of this drug may benefit women suffering from endometriosis in the future."
Endometriosis is a disease in which endometrial tissue or the tissue resembling the lining of the uterus is found in the pelvic region. Active and fibrotic endometrial tissue can cause severe pain during each menstrual cycle. Symptoms include painful menstruation, abnormal bleeding during menstruation, pain that surfaces during or after intercourse, fatigue, painful urination or bowel movements during periods and gastrointestinal upsets. The disease affects 11 million women in the U.S. alone. It is the leading cause of infertility among reproductive age women and the most common non-malignant gynecological disorder in the U.S. 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). These side effects are the outcome of delivering the drug systemically and often result in a discontinuation of treatment.
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.
"In this early trial, FP1096 has shown a positive impact on the quality of life for women affected with endometriosis. Our investigational drug has significantly reduced the pain associated with endometriosis and at the same time has shown minimal systemic side effects. FemmePharma is looking forward to continuing the clinical development of FP1096 and ultimately bringing it to market," said Gerianne Tringali DiPiano, FemmePharma's President and CEO.
Source: FemmePharma, Inc.