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Osphena ™ - Ospemifene

Osphena ™ - Ospemifene. Manufacturer: Shionogi INC FDA Approval Date: 02/26/13. Osphena ™ - Ospemifene Clinical Application. Indications: Treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Place in therapy:

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Osphena ™ - Ospemifene

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  1. Osphena™ - Ospemifene Manufacturer: Shionogi INC FDA Approval Date: 02/26/13

  2. Osphena™ - OspemifeneClinical Application • Indications: • Treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. • Place in therapy: • Monotherapy for those patients receiving no benefits using other estrogen therapies • Continue to have painful intercourse after menopause

  3. Osphena™ - OspemifeneClinical Application • Contraindications: • Pregnancy • Active DVT • Pulmonary embolism • History of these conditions • Black Box warnings: None • Precautions: • Use of unopposed estrogen in women with an intact uterus is associated with an increased risk of endometrial cancer. • An increased risk of DVT and stroke reported with oral conjugated estrogens

  4. Osphena™ - OspemifeneClinical Application • Pregnancy: • Category X • Lactation: • Excretion in breast milk unknown • Use is not recommended

  5. Osphena™ - OspemifeneDrug Facts • Pharmacology: • A selective estrogen receptor modulator (SERM) • Osphena has agonistic effects on the endometrium • Induces changes to the vaginal epithelium • Decreases vaginal pH

  6. Osphena™ - OspemifeneDrug Facts • Pharmacokinetics: • A – Tmax 2h; absorption affected by food • D – protein binding >99% bound to serum proteins • M – Hepatic via CYP3A4, 2C9, and 2C19 • E – Feces (75%); urine (7%; <0.2% as unchanged drug. Elimination t1/2 26 h

  7. Osphena™ - OspemifeneDrug Interactions • Drug Interactions – Object Drugs: • Fluconazole  (2.7 fold • Ketoconazole  (1.4 fold) • Rifampin  (58%)

  8. Osphena™ - OspemifeneDrug Interactions • Drug Interactions – Precipitant Drugs: • Fluconazole  (2.7 fold • Ketoconazole  (1.4 fold) • Rifampin  (58%)

  9. Osphena™ - OspemifeneAdverse Effects • Common Adverse Effects: • Hot flushes (7.5%)[2.6%] • Muscle spasm (3.2%)[0.9%] • Vaginal discharge (3.8%)[0.3%] • Hyperhidrosis (1.6%)[0.6%] • Serious Adverse Effects: • DVT • Hemorrhagic stroke • Thromboembolic stroke

  10. Osphena™ - OspemifeneMonitoring Parameters • Efficacy Monitoring: • None recommended • Toxicity Monitoring: • Signs of endometrial cancer in female patients with uterus. • Assess need for therapy at regular intervals. • Signs/symptoms of stroke and VTE

  11. Osphena™ - OspemifenePrescription Information • Dosing: • 60mg orally once daily with food • Cost: $189 • Source:Medi-Span (via Lexi-comp online) • Accessed 03/31/2014

  12. Osphena™ - OspemifeneLiterature Review • A randomized, double-blind, parallel-group design to compare • The efficacy, safety, and tolerability of oral ospemifene 60 mg/day versus placebo Portman et al. Menopause 2013; 20(6):623-630

  13. Osphena™ - OspemifeneLiterature Review • Primary endpoints: • Change from baseline to week 12 of the following: • Percentage of parabasal cells • Percentage of superficial cells • Vaginal pH • Severity of the most bothersome symptom (MBS) • Secondary Endpoint: • Change in the severity of dyspareunia Portman et al. Menopause 2013; 20(6):623-630

  14. Osphena™ - Ospemifene Literature Review • N = 605 • Inclusion criteria: • Postmenopausal women between 40-80 years • Negative Pap test result / lacked an intact cervix • Negative mammogram result < 9 months before randomization • Normal breast examination result at screening • Exclusion criteria: • BMI of >37 kg/m2 • Vaginal infection requiring medication • Strong CYP 3A4 inhibitors Portman et al. Menopause 2013; 20(6):623-630

  15. Osphena™ - Ospemifene Literature Review Portman et al. Menopause 2013; 20(6):623-630

  16. Osphena™ - Ospemifene Literature Review Portman et al. Menopause 2013; 20(6):623-630

  17. Osphena™ - OspemifeneLiterature Review Mean (SD) change from baseline to week 12/last observation carried forward in the percentage of parabasal cells in the ITT and PP populations. P < 0.0001 versus placebo Mean (SD) change from baseline to week 12/last observation carried forward in the vaginal pH of the ITT and PP populations. P < 0.0001 versus placebo. Portman et al. Menopause 2013; 20(6):623-630

  18. Osphena™ - OspemifeneLiterature Review Mean (SD) change from baseline to week 12/last observation carried forward in the percentage of superficial cells in the ITT and PP populations. P < 0.0001 versus placebo Mean (SD) change from baseline to week 12/last observation carried forward in the MBS severity scores of the ITT and PP populations. P = 0.0001 versus placebo. P = 0.0004 Portman et al. Menopause 2013; 20(6):623-630

  19. Osphena™ - Ospemifene Literature Review • 12 weeks of treatment with ospemifene 60 mg/day induced statistically significant beneficial changes: • Parabasal cells decreased by 40.2% • Superficial cells increased by 12.3% • Compared with a 0% reduction and a 1.7% increase in the placebo group; P < 0.0001 • Vaginal pH decreased by -0.94 • Compared with -0.07 in the placebo group; P < 0.0001 • Self-reported MBS severity score of dyspareunia decreased by -1.5 • Compared with -1.2 in the placebo group; P = 0.0001 Portman et al. Menopause 2013; 20(6):623-630

  20. Osphena™ - Ospemifene Literature Review • Study Conclusion: • Ospemifene 60 mg/day vs placebo effectively • Reduces the physiological signs of VVA and dyspareunia in postmenopausal women • Did not induce significant estrogenic effects on endometrial tissue • Reduction in nonhormonal lubricant use • The first oral alternative to vaginal estrogens for the treatment of dyspareunia associated with VVA Portman et al. Menopause 2013; 20(6):623-630

  21. Osphena™ - OspemifeneSummary • Osphena is an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause • Osphena selectively binds to estrogen receptors, inducing changes to the vaginal epithelium and decreasing vaginal pH • There is an increased risk of endometrial cancer in women with a uterus who uses unopposed estrogens • The recommended daily dose is 60mg tablet taken orally once daily with food • The most common side effects include hot flushes, genital discharge, and muscle spasms • Osphena may be used as a monotherapy in those patients that have had no benefits using other estrogen therapies and continue to have painful intercourse after menopause Portman et al. Menopause 2013; 20(6):623-630

  22. Osphena™ - OspemifeneReferences • http://www.osphena.com • Osphena package insert. Shionogi INC. Feb 2013. • Osphena. Lexicomp Drug Information. Accessed through UpToDate. Accessed on March 30, 2014 • Portman DJ, Bachmann GA, Simon JA, et al. Ospemifene, a Novel Selective Estrogen Receptor Modulator for Treating Dyspareunia Associated with Postmenopausal Vulvar and Vaginal Atrophy. Menopause 2013; 20(6):623-630 • Tan O, Bradshaw K, and Carr BR, "Management of Vulvovaginal Atrophy-Related Sexual Dysfunction in Postmenopausal Women: An Up-to-Date Review. Menopause 2012; 19(1):109-17

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