June 4, 2007
August 1, 2007
Moderate to severe vasomotor menopausal symptoms.
Estradiol 0.25mg, 0.5mg, 1mg; per packet; topical gel.
Goble & Associates (professional and DTP)
The Reilly Group (PR)
Thisnew hormone therapy offers the lowest approved dose of estradiol available forthe treatment of moderate to severe hot flashes associated with menopause,according to the manufacturer. As part of the launch, ad agency Goble &Assoc. helped develop a new patient-facing website, www.DivigelUS.com. Thetransdermal therapy may be attractive to women who have been reluctant to takeolder hormone therapies with higher doses. Another possible selling point isthe green angle: Divigel is derived from plant sources, unlike certain olderestrogen therapies derived from the urine of pregnant mares.
|Hormones, estrogens US sales ($000s) last 5 years|
|Source: IMS Health, Oct. 2007
|Top 5 hormones, estrogens|
|Jan.-July ’07 US sales ($000s)||% sales growth over Jan.-July ‘06|
PREMARIN VAGINAL (Wyeth)
ESTRACE (Warner Chilcott)
|Source: IMS Health, Oct. 2007
Study planned, 2008
Also in the Pipeline(according to Adis R&D Insights)
Drug: Aprela, CE/BZA
Manufacturer: LigandPharmaceuticals, Wyeth
Indication: Postmenopausal osteoporosis prevention, Vaginalatrophy, Vasomotor symptoms
Active Ingredients: Conjugated estrogens/bazedoxifene
Source: Wolters Kluwer Health, Oct. 2007
The addition of exogenous estrogens helps to alleviate thevasomotor symptoms associated with declining estrogen levels.
Divigel (estradiol 0.1%) is a clear, colorless, alcohol-based gelthat is designed to deliver sustained circulating concentrations of estradiolwhen applied once daily to the skin.
The efficacy of this product in treating vasomotor symptomsin post-menopausal women was evaluated in a 12-week, double-blind,placebo-controlled trial involving 495 patients. Divigel 0.25g, 0.5g, or 1g(corresponding to 0.25mg, 0.5mg, and 1mg estradiol), applied once daily to thethigh, was compared to placebo. At week 4, Divigel at doses of 0.5g and 1g/dayresulted in significant reductions in the median daily frequency and the mediandaily severity of moderate to severe hot flushes compared to placebo; at week7, treatment with Divigel 0.25g/day also reached statistical significance inimprovements in these measurements. The statistically significant reductions inmedian daily frequency and severity of hot flashes were continued through week12 for all three Divigel doses compared to placebo.
Hypertension, edema, chloasma, mastodynia, headache, glucoseintolerance, vaginitis, changes in bleeding patterns, weight changes,intolerance to contact lenses, increased risk of gallbladder disease,thromboembolic events.
Apply entire contents of 1 packet once daily to 5” x 7” areaof dry intact skin on upper thigh; alternate right and left thigh for dailyapplication. Initially 0.25g (corresponding to 0.25mg estradiol)/day;individualize. Allow gel to dry before dressing; do not wash area for at least1 hr after application; wash hands after use.
Undiagnosed abnormal genital bleeding. Breast or otherestrogen-dependent neoplasias. Hypercoagulability. Thrombophlebitis orthromboembolic disorders. Hepatic dysfunction or disease. Pregnancy.
Patients with intact uterus should receive a progestin toavoid endometrial hyperplasia. Do initial complete physical and repeat annually(include BP, mammogram, Pap smear). Reevaluate periodically; use lowesteffective dose. Endometriosis. Severe hypocalcemia. Bone disease associatedwith hypercalcemia. Discontinue if jaundice or hypercalcemia occurs, and duringimmobilization or at least 2 weeks before surgery associated with increasedrisk of thromboembolism. Hypertriglyceridemia. Porphyria. Hepatic hemangioma.SLE. Discontinue if sudden visual changes occur pending evaluation. Product isflammable. Nursing mothers.
May be potentiated by CYP3A4 inhibitors. May be antagonizedCYP3A4 inducers. May be affected by application of sunscreen.