PHILADELPHIA, Oct. 18 /PRNewswire/ -- Ferring Pharmaceuticals introduced today the Q-Cap(TM), the first device enabling needle-free reconstitution (process of dissolving medication in diluent) of fertility treatments. It is for exclusive use with the Company's human-derived fertility treatments and will be packaged with Bravelle(R) (urofollitropin for injection, purified). The device allows user-friendly reconstitution of medication(s) in a single vial, in single or mixed protocols, simplifying preparation for injection, and eliminating product waste and accidental needle sticks. The Q-Cap(TM) was previewed at the 60th Annual Meeting of the American Society for Reproductive Medicine (ASRM) in Philadelphia, October 16-20, 2004.
(Photo: http://www.newscom.com/cgi-bin/prnh/20041018/NYM008 )
"In a recent survey by the International Council on Infertility Information Dissemination (INCIID), 77% of the 537 in vitro fertilization (IVF) polled patients reported reconstitution as the most stressful part of IVF therapy," said William Garbarini, director of marketing, Ferring Pharmaceuticals. "Part of that stress was specifically attributed to the use of needles. Since the Q-Cap(TM) is needle-free, it eliminates patients' anxiety associated with needle use during this process and increases comfort levels, making patients more confident in their self-treatment while ensuring that the full prescribed medication dose is administered from the vial."
The Q-Cap(TM) provides fast and easy reconstitution that is consistent with the traditional needle and syringe injection method that patients have become accustomed to and may need to use with other medications prescribed during their treatment cycle. It allows patients to easily withdraw the full contents of each vial needle-free. It does not interfere with the patient's ability to withdrawal her full dose without wasting product.
The device can also be used with Ferring's Repronex(R) (menotropins for injection, USP) fertility treatment.
How Q-Cap(TM) Works
For reconstitution, the patient twists the Q-Cap(TM) onto the syringe, pushes the tip through the diluent vial's rubber stopper, and pulls back on the plunger to remove the diluent. Next, the patient places the Q-Cap(TM) on the vial containing the Bravelle(R) or Repronex(R) powder, pushes the tip into the rubber stopper, then slowly injects the diluent into the vial and swirls the diluent and medication until the medication is dissolved. The solution can be used to dissolve up to six vials in one syringe.
The Q-Cap(TM) can be used to reconstitute medication(s) in one syringe regardless of protocol and allows the patient to administer only one injection per day. If more than one medication is required, the patient simply repeats the process with the additional vial(s) of medication(s) before attaching the injection needle to the vial. This improved reconstitution process reduces time required to educate patients since it mirrors the reconstitution process with the standard needle and syringe technique, eliminates accidental needle sticks and eliminates product waste.
"The Q-Cap(TM) is a new feature designed to make self-treatment with Bravelle(R) easier and less stressful for patients," said Dr. Richard T. Scott, Jr., Director and Managing Partner of Reproductive Medicine Associates of New Jersey. "Another benefit of the Q-Cap(TM) is that it requires only one injection in mixed protocols, whereas other devices require at least two. By using the Q-Cap(TM), different ratios of Bravelle(R) and Repronex(R) can be delivered in one syringe to meet individual patient needs."
The Q-Cap(TM) will be commercially available in late 2004. For more information, complete instructions for use and a video demonstrating the reconstitution process with Q-Cap(TM), please visit http://www.ferringfertility.com/.
About Bravelle(R) and Repronex(R)
Bravelle(R), a highly purified human-derived follicle-stimulating hormone (hFSH) for infertility treatment, contains 75 IU of FSH and up to two percent LH activity. Bravelle(R), administered SC or IM in conjunction with hCG, is indicated for ovulation induction following pituitary suppression. Bravelle(R), administered SC in conjunction with hCG, is also indicated for multiple follicular development during ART cycles in patients who have previously received pituitary suppression.
Repronex(R) is the only human menopausal gonadotropin (hMG) on the market and is approved for both subcutaneous and intramuscular administration. Bravelle(R) and Repronex(R), like all gonadotropins, are potent substances capable of causing mild to severe adverse reactions, including OHSS (incidence of 6.0% and 3.5%, respectively), with or without pulmonary or vascular complications, in women undergoing therapy for infertility.
Both treatments are marketed by Ferring Pharmaceuticals Inc., a world leader in naturally occurring protein hormones. Only physicians thoroughly familiar with infertility treatment, including the risk of multiple births and adverse reactions, should prescribe these medications. Like other products for ovarian stimulation, treatment with Repronex(R) and/or Bravelle(R) may result in multiple gestations.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals, part of the Ferring Group, a privately owned, international pharmaceutical company, markets Bravelle(R), Repronex(R) and Novarel(TM) in the U.S. to infertility specialists and their patients. The Ferring Group specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/gynecology and infertility. For more information, call 888-337-7464 or visit http://www.ferringusa.com/ or http://www.ferringfertility.com/.
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