October 30, 2017
FERRING PHARMACEUTICALS PRESENTS NEW DATA COMPARING MENOPUR® (menotropins for injection) TO rFSH IN HIGH RESPONDER PATIENTS
PARSIPPANY, NJ (October 30, 2017) – Today Ferring Pharmaceuticals announced results from MEGASET HR, a 620 patient, prospective study comparing MENOPUR (highly purified menotropin, or HP-hMG) to recombinant follicle stimulating hormone (rFSH) in patients predicted to be high-responders to ovarian stimulation with gonadotropins. Patients treated with MENOPUR demonstrated a comparable ongoing pregnancy rate and a low incidence of ovarian hyperstimulation syndrome (OHSS) compared to rFSH. These results were presented for the first time at the American Society for Reproductive Medicine (ASRM) Scientific Congress & Expo in San Antonio, Texas.
The MEGASET HR study met its primary non-inferiority endpoint, with MENOPUR-treated patients reporting a 29.7% ongoing pregnancy rate per cycle start in the fresh cycle compared to 25.6% for rFSH. In addition, the ongoing pregnancy rate per blastocyst transfer was 45.8% for MENOPUR and 41.4% for rFSH, respectively. Regarding safety, the overall incidence of adverse events reported was 57.7% with MENOPUR and 70.6% with rFSH. The adverse events reported included the incidence of ovarian hyperstimulation syndrome (OHSS), a condition in which the ovaries become swollen and painful following the use of injectable medications to stimulate ovulation and is especially prevalent in these patients.1 OHSS also affects other parts of the body and can be life-threatening. In this study, the OHSS rates were 9.7% in patients treated with MENOPUR vs 21.4%, P<0.05, in the rFSH treatment arm.
The authors of the MEGASET HR study data presented at ASRM concluded that MENOPUR provided safe ovarian stimulation without compromising efficacy, versus rFSH. “The MEGASET HR data supports MENOPUR as an efficacious treatment option in women undergoing controlled ovarian stimulation,” said Joan-Carles Arce, MD, Ph.D., Chief Scientific Officer, Ferring Pharmaceuticals. “While MENOPUR has been commercially available in the U.S. for more than 13 years, we continue to ask questions and search for answers that help expand our knowledge of the clinical efficacy and safety profile of the product in the treatment of infertility.”
Additional data from the MEGASET HR Study is anticipated for release in 2018.
About the MEGASET HR Study
The MEGASET HR study is a multicenter, randomized, open-label, assessor-blind, non-inferiority study designed to compare the safety and efficacy of MENOPUR (highly purified menotropin, or HP-hMG) vs. recombinant follicle stimulating hormone (rFSH) in high responder patients undergoing in vitro fertilization (IVF). The study included 620 ovulatory women between the ages of 21 and 35, with a body mass index (BMI) of 18-30 kg/m2, and serum anti-Müllerian hormone (AMH) ≥ 5 ng/mL. Subjects were randomized in a 1:1 ratio to a 150 IU start dose of MENOPUR or rFSH in a Gonadotropin-releasing hormone (GnRH) antagonist cycle. Dose adjustments were permitted starting on the sixth day of stimulation based on follicular response. Dosing could be adjusted every day by 75 IU per day with a maximum and minimum gonadotropin dose of 300 and 75 IU/day, respectively, for no more than 20 days. The primary non-inferiority endpoint, ongoing pregnancy rate, was defined as the presence of at least 1 intrauterine pregnancy with a detectable fetal heartbeat at 10-11 weeks gestation (8-9 weeks after blastocyst transfer in the fresh cycle).
MENOPUR® (menotropins for injection), administered subcutaneously, is indicated for the development of multiple follicles and pregnancy in ovulatory patients participating in an Assisted Reproductive Technology (ART) program.
Important Safety Information
MENOPUR is contraindicated in women who have: a high FSH level indicating primary ovarian failure, presence of uncontrolled non-gonadal endocrinopathies, tumors of the pituitary gland or hypothalamus, sex hormone dependent tumors of the reproductive tract and accessory organs, abnormal uterine bleeding of undetermined origin, ovarian cysts or enlargement of undetermined origin, not due to polycystic ovary syndrome, or prior hypersensitivity to menotropins or MENOPUR. MENOPUR is not indicated in women who are pregnant and may cause fetal harm when administered to a pregnant woman.
MENOPUR should only be used by physicians who are thoroughly familiar with infertility problems. MENOPUR is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS), with or without pulmonary or vascular complications, in women undergoing therapy for infertility. Ovarian torsion has been reported after gonadotropin treatment. Serious pulmonary conditions and thromboembolic events have been reported with MENOPUR. There have been infrequent reports of ovarian neoplasms with MENOPUR. Multiple pregnancies, spontaneous abortion, congenital malformations and ectopic pregnancies have occurred following treatment with MENOPUR.
The most common adverse reactions (≥2%) in ART include: abdominal cramps; abdomen enlarged; abdominal pain; headache; injection site pain and reaction; injection site inflammation; OHSS.
Please see here for full Prescribing Information for MENOPUR.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing and marketing innovative products in the fields of reproductive health, urology, gastroenterology, endocrinology and orthopedics. For nearly two decades, Ferring has provided a range of therapies to help women along every step of the fertility journey; however, equally important, the company has been committed to raising awareness of infertility, providing support to patients, and partnering with third-party organizations dedicated to impacting change. To learn more about Ferring, visit http://www.ferringUSA.com.
For more information about Ferring Reproductive Health, please visit www.ferringfertility.com.
1. Ovarian Hyperstimulation Syndrome. Mayo Clinic. Updated August 3, 2017. Available at: http://www.mayoclinic.org/diseases-conditions/ovarian-hyperstimulation-syndrome-ohss/symptoms-causes/syc-20354697. Accessed October 6, 2017.
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