PARSIPPANY, N.J., Aug. 31 /PRNewswire/ -- Endometrin(R) (progesterone) Vaginal Inserts, 100 mg showed clear advantages over Crinone* (progesterone gel) for progesterone supplementation, according to the results of a new pharmacokinetic (PK) study. Progesterone is necessary to increase endometrial receptivity for implantation of an embryo and to support early pregnancy.
ENDOMETRIN(R) rapidly reached higher progesterone serum concentrations, produced greater systemic exposure (AUC 0-24), achieved steady state more rapidly, and cleared more rapidly after termination of therapy than Crinone. The study results were published online in Fertility & Sterility, July 15, 2009.
"We are extremely pleased to bring the fertility community a progesterone supplement that dissolves, achieves steady state and clears faster than gel while providing convenience and comfort to patients," said Ed Trott, vice president, medical affairs. "The study results support the benefits provided by Endometrin(R)'s unique mechanism of action, or as we like to say, Dissolves. Delivers. Done."
About the Study
The randomized, open-label, parallel design PK study tested three groups of six healthy subjects, randomized to take Endometrin(R) two times a day or three times a day or Crinone 8% gel daily. Testing was done for a single day and for multiple days. On the single day of dosing, mean C(max) was 17.0 ng/mL in the two times a day group, 19.8 ng/mL in the three times a day group, and 6.8 ng/mL in the gel group. The 24-hour systemic exposure AUC (0-24) was 217 ng h/mL in the two times a day insert group, 284 ng h/mL in the three times a day group, and 81ng h/mL in the gel group.
During the multiple days of dosing, ENDOMETRIN(R) treatments reached steady state within the first two days (24-32 hours), much more rapidly than the gel, which had not reached steady state by 5 days. At 5 days, the Endometrin(R) treatments produced sustained progesterone concentrations exceeding 10 ng/mL across 24 hours. The results suggest that ENDOMETRIN((R)) can reach a targeted concentration range in a substantially shorter time than Crinone. Both ENDOMETRIN(R) groups demonstrated a higher C(max)( )than the Crinone group, with greater systemic exposures. Both the vaginal inserts and the gel were generally safe and well tolerated, and all adverse events were mild.
ENDOMETRIN(R) administered as a progesterone vaginal insert is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment for infertile women.
Important Safety Information
Only physicians thoroughly familiar with infertility treatment should prescribe ENDOMETRIN(R). In clinical trials (n=808), adverse reactions that occurred at a rate greater than or equal to 2 percent included: uterine spasm (3% to 4%) and vaginal bleeding (3%). Vaginal irritation, itching, burning or discomfort, urticaria, and peripheral edema were reported at an incidence of less than 2 percent. ENDOMETRIN(R)( )is expected to have adverse reactions similar to other drugs containing progesterone (breast tenderness, bloating, mood swings, irritability, and drowsiness). ENDOMETRIN(R)( ) is contraindicated in women who have or have had previous allergic reactions to progesterone or any of the ingredients in ENDOMETRIN(R)( ); a known missed abortion or ectopic pregnancy; liver disease; known or suspected breast cancer; active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals, part of the Ferring Group, a privately owned, international pharmaceutical company, manufactures and markets the largest family of fertility treatments of any manufacturer in the U.S. The Company markets MENOPUR(R) (menotropins for injection, USP), BRAVELLE(R) (urofollitropin for injection, purified), REPRONEX(R)( )(menotropins for injection, USP), NOVAREL(R) (chorionic gonadotropin for injection, USP) and ENDOMETRIN(R) (progesterone) Vaginal Insert 100 mg in the U.S. to infertility specialists and their patients. Ferring also offers the Q-CAP((TM)), the first and only needle-free reconstitution device, for use with its fertility treatments.
Ferring's line of urology products includes FIRMAGON(R)( )(degarelix for injection) and PROSED(R) DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate). Ferring's orthopaedic product includes EUFLEXXA((TM)) (1% sodium hyaluronic acid). Other products include ACTHREL(R) (corticorelin ovine triflutate for injection) and DESMOPRESSIN.
The Ferring Group specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/ gynecology, infertility and orthopaedics. For more information, call 888-337-7464 or visit www.ferringusa.com or www.ferringfertility.com.
*Crinone is a registered trademark of Columbia Laboratories.
Please visit www.ferringfertility.com for Full Prescribing Information for ENDOMETRIN(R).
|SOURCE Ferring Pharmaceuticals|
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