Product
Endometrin
Approval Date
June 21, 2007
Release Date
November 08, 2007
Company
Ferring
Class
Progestin
Indication
To support embryo implantation and early pregnancy bysupplementation of corpus luteal function as part of an Assisted ReproductiveTechnology (ART) treatment program for infertile women.
Active ingredient
Progesterone 100mg; vaginal insert
Agency Roster
Trio Communications (professional/consumer)
ICC
MarketingStrategy/Execution
Ferring’s Endometrin may be the first new option in over a decade for patients who need a progesterone-based supplement as part of their fertility program. Lowe’s Trio Communications, tasked with professional and consumer advertising will stress greater patient satisfaction with no messy gels, annoying build-up or painful injections. The professional campaign so far includes an ad in the Journal of Fertility and Sterility, as well as personal selling.
The Market
| Hormones, progestogen inj US sales ($000s) last 5 years | |
| 2006 | $7,929 |
| 2005 | $6,776 |
| 2004 | $6,929 |
| 2003 | $7,098 |
| 2002 | $8,780 |
| Source: IMS Health, Nov. 2007 |
|
| Top 5 hormones, progestogen inj | ||
| Jan.-Sept. ’07 US sales ($000s) | % sales growth over Jan.-Sept. ‘06 | |
| PROGESTERONE IN OI | $4,827 | 14% |
| DEPO-PROVERA (Pfizer) | $1,453 | -4% |
| PROGESTERONE | 0 | -56% |
| HYDROXYPROGESTERON | — | *** |
| HYLUTIN (Hyrex) | — | *** |
| Source: IMS Health, Nov. 2007 |
||
Also in the Pipeline(according to Adis R&D Insight)
No competitor products in phase III or preregistration, US
Recent MM&MCoverage
The Top 50: Integrated Communications
Pharmacology
Progesterone supplementation is used to provide support forthe luteal phase, preparing the endometrium for implantation of the embryo, andfor early pregnancy. Endometrin is a quickly dissolving tablet containingmicronized progesterone that is vaginally inserted. After insertion, the tabletdisperses locally, rapidly achieving local levels of progesterone.
Clinical trials
An active-controlled study evaluated the efficacy of 10weeks of treatment with two different dosing regimens of Endometrin (100mgtwice daily and 100mg three times daily). Efficacy was assessed on theend-point of ongoing pregnancies, defined as the presence of at least one fetalheartbeat seen on ultrasound at 6 weeks post-embryo transfer. The ongoingpregnancy rates for those treated with both regimens were non-inferior to theongoing pregnancy rate for patients treated with the active comparator.
Adverse reactions
GI upset, abdominal pain, post-oocyte retrieval pain,ovarian hyperstimulation syndrome, headache, uterine spasm, vaginal bleeding,fatigue, urinary tract infection.
Adults
100mg vaginally 2 or 3 times daily starting at oocyteretrieval for up to 10 weeks total duration. =35yrs: efficacy not clearlyestablished; see literature.
Children
Not applicable.
Contraindications
Breast carcinoma. Liver dysfunction or disease. Missedabortion. Ectopic pregnancy. Thrombophlebitis or thromboembolic disorders.
Precautions
Depression. Discontinue if signs of thrombotic disorders(eg, thrombophlebitis, cerebrovascular disorders, pulmonary embolism, retinalthrombosis) occur. Pregnancy outcome: see literature. Nursing mothers.
Interactions
Concomitant other vaginal products (eg, antifungals): notrecommended.
