June 27, 2016
Allergan and Gedeon Richter announced positive results from Venus I, one of two pivotal phase III clinical trials evaluating the efficacy and safety of ulipristal acetate in women with uterine fibroids. The study included 157 patients, with 101 patients randomized to ulipristal acetate 5 and 10mg and 56 to placebo. The study met all the co-primary and secondary endpoints with both ulipristal treatment arms achieving statistically significant results over placebo (p<0.0001). The co-primary efficacy endpoints were the percentage of patients with absence of uterine bleeding and time to absence of uterine bleeding. Significantly more patients in the 10 mg group (58.3%; p<0.0001) and the 5mg group (47.2%; p<0.0001) achieved absence of bleeding compared to placebo (1.8%). There were no treatment-related serious adverse events. No patients discontinued ulipristal acetate treatment due to adverse events. The most common adverse events (5%) on ulipristal acetate treatment were hypertension (N=6), blood creatine phosphokinase increased (N=5), hot flush (N=5), and acne (N=3). Venus I is the first clinical trial to report topline results. The second of two clinical trials, Venus II is anticipated to be completed this year with topline results expected in the first half of 2017. A new drug application for the treatment of uterine fibroids is planned to be submitted in 2017.
May 30, 2016
Allergan and Gedeon Richter issued results from one of two pivotal phase III clinical trials evaluating the efficacy and safety of ulipristal acetate in women with uterine fibroids. The study was a multicenter, randomized, double-blind, placebo-controlled clinical trial in premenopausal women between 18 and 50 years old with cyclic (22 to 35 days) abnormal uterine bleeding in four of the last six menstrual cycles. Eligible patients were randomized 1:1:1 to ulipristal acetate 5mg, 10mg or placebo for one 12-week treatment course followed by a 12- week treatment-free follow-up period. The study included 157 patients, with 101 patients randomized to ulipristal acetate 5 and 10mg and 56 to placebo. The study met all the co-primary and secondary endpoints with both ulipristal treatment arms achieving statistically significant results over placebo (p<0.0001). The co-primary efficacy endpoints were percentage of patients with absence of uterine bleeding and time to absence of uterine bleeding. Significantly more patients in the 10mg group (58.3%; p<0.0001) and the 5mg group (47.2%; p<0.0001) achieved absence of bleeding compared to placebo (1.8%). A new drug application for the treatment of uterine fibroids is planned to be submitted in 2017.
January 14, 2013
Repros Therapeutics released results from a phase II trial of vaginally administered Proellex for the treatment of symptomatic fibroids. This blind, placebo run-in, four-arm study enrolled 40 females with symptomatic uterine fibroids. Subjects received 3mg, 6mg, 12mg or 24mg of Proellex. Data demonstrated the 12mg dose of Proellex exhibited a statistically significant difference (p<0.05) compared to the pooled data from the 3mg and 6mg doses for all three measures. Roughly 58% of the women on the 12mg dose ceased menstruation, whereas only 18% of the combined 3mg and 6mg doses stopped. Unexpectedly, the 24mg dose exhibited lower exposure than the 12mg dose which, Repros believes, may result from the hydrophobic nature of the active ingredient and the low volume of excipient used in order to prevent vaginal leakage. Proellex was well tolerated. Repros has initiated an extension study, plans to request an end of phase II meeting with the FDA and pursue the 12mg dose in phase III trials.
May 24, 2010
PregLem issued positive results from a phase III trial of Esmya for the treatment of uterine fibroids (myoma). This randomized, parallel group, double-blind, double-dummy, active comparator-controlled, multi-center study, PEARL-2, enrolled 307 pre-operative, pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma. The subjects received Esmya orally once daily at dosages of 5 and 10 mg or the standard of care, leuprorelin, 3.75 mg monthly injections. Esmya met the non inferiority efficacy endpoint versus Leuprorelin: to reduce excessive uterine bleeding caused by uterine myomas. The primary endpoint was change from baseline in the bleeding intensity score. This was measured as a percentage of subjects with a reduction of PBAC (Pictorial Blood Assessment Chart) score to lower than 75 after 3 months of treatment. In addition, Esmya demonstrated superior safety and tolerance with statistical significance versus Leuprorelin.
April 9, 2007
Repros reported positive final results from aphase II trial of Proellex for the treatment of uterine fibroids. Thisdouble-blind trial compared two doses of Proellex (12. 5 mg and 25 mg) toplacebo. The primary endpoint was reduction in excessive menstrual bleeding,measured using the Pictorial Blood Loss Assessment Chart (PBAC). Otherendpoints included pain, assessed using the McGill pain score and various othersymptoms of fibroids measured using the Uterine Fibroid Symptom and Quality ofLife (UFS-QOL) questionnaire. Of 127 subjects initially enrolled in the trial,96 completed treatment. The mean PBAC scores after three months were 6. 0 and16.9 for the 25 mg and 12.5 mg groups, respectively, versus a score of 109. 5for placebo (p = less than 0.0001).When compared to baseline, a significantreduction in McGill pain scores were observed for 44.4% of those on the 25mgdose of Proellex and 29.2% of those on the 12.5 mg dose versus 18. 2% of thoseon placebo. A statistically significant reduction in symptoms associated withfibroids was also seen. After three months the subjects receiving 12. 5 and 25mg doses of Proellex had UFS-QOL scores of 17. 4 and 14. 9, respectively,compared to 40.1 for the placebo group. Treatment was well tolerated at bothdoses studied. Based on the results, Repros plans to move forward with thedevelopment of Proellex.
February 28, 2005
Zonagen announced interim results from a phase I/II trial of Progenta, their fixed-dose formulation of four orally-active selective progesterone receptor modulators under investigation for the treatment of uterine fibroids. Three month data from the study yielded evidence of efficacy in reducing mean fibroid cross sectional area, with a reduction of 16.2%, 35.1%, and 40.9% for the low, middle and high dose regimens of Progenta (respectively, compared to 37.5% for approved therapy with Lucrin and 5% for placebo. The reductions seen in the middle and high dose Progenta groups and the Lucrin group were statistically significant, vs. placebo (p<0.05). Overall adverse events were mild, with headaches occurring most frequently overall and more frequently with Lucrin than any other treatment. This double-blind, placebo-and-active-controlled trial enrolled 30 women with uterine fibroids in Poland, who received one of three oral doses of Progenta (12.5 mg, 25 mg or 50 mg), approved therapy with Lucrin, or placebo once daily for 3 months.
November 15, 2004
Zonagen has issued one-month interim findings from a phase I/II trial of Progenta, an orally-active selective progesterone receptor modulator, for the treatment of uterine fibroids. The preliminary data demonstrate that the highest Progenta dose regimen produced a significant 24.2% reduction in fibroid size, compared to baseline (p=0.013). No other trial regimen, including approved therapy, has thus far produced a significant reduction in fibroid size. This ongoing, double-blind, placebo-controlled study has enrolled a total of 30 women with confirmed uterine fibroids into one of three regimens of daily Progenta (12.5 mg, 25 mg or 50 mg), a standard regimen of Lucrin, or placebo. Dosing will conclude in the second half of December 2004, with final results following soon after. Final results will include assessments of changes in bone mineral density and hemoglobin levels, in addition to fibroid size.
May 17, 2004
AEterna Laboratories and Zentaris GmbH reported positive results from six phase II trials investigating cetrorelix, a luteinizing hormone releasing hormone antagonist for the treatments of benign prostatic hyperplasia (BPH), uterine myomas and endometriosis. The placebo-controlled endometriosis study demonstrated that cetrorelix was associated with a rapid response and improvement of endometriosis-related symptoms. Placebo-controlled uterine myoma trials demonstrated that subcutaneous administrations of cetrorelix demonstrated a reduction of myoma/uterine volume within one month. Results from two placebo-controlled BPH trials demonstrated a dose-dependent improvement in clinical symptoms, including IPSS (International Prostate Symptom Score) and maximum uroflow in the cetrorelix treatment group compared with the placebo group. Full results will be presented during the 18th World Congress of the International Federation of Fertility Societies in Montreal.
FemmePharma reported positive results from a phase II trial investigating FP1096, an intravaginally delivered drug for the treatment of endometriosis. Results showed that the primary efficacy endpoint, change in the Biberoglu and Behrman Symptom Score from baseline to treatment end, demonstrated a statistically significant decrease in symptoms. The multicenter, prospective, open-label study enrolled 30 subjects with endometriosis at four sites in the U.S. Secondary efficacy endpoints included a pain assessment questionnaire, a quality of life measure and a daily diary assessment. Results were reported at the 52nd Annual Clinical Meeting of The American College of Obstetricians and Gynecologists.