Ogen (Estropipate) - Summary

OGEN SUMMARY

OGEN^®
estropipate tablets, USP

OGEN (estropipate tablets), (formerly piperazine estrone sulfate), is a natural estrogenic substance prepared from purified crystalline estrone, solubilized as the sulfate and stabilized with piperazine. It is appreciably soluble in water and has almost no odor or taste — properties which are ideally suited for oral administration. The amount of piperazine in OGEN is not sufficient to exert a pharmacological action. Its addition ensures solubility, stability, and uniform potency of the estrone sulfate.

OGEN is indicated in the:

1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.
2. Treatment of moderate to severe symptoms of vulval and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
4. Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate.
   The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400–800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.

NEWS HIGHLIGHTS

Media Articles Related to Ogen (Estropipate)

Genentech And Biogen Idec Receive A Complete Response From The FDA For Rituxan For Chronic Lymphocytic Leukemia
Source: Health News from Medical News Today [2009.11.19]
Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today that the U.S.

Linkage Biosciences Unveils LinkSeqTM -- A Revolutionary New Tool For Immunogenetic Testing
Source: Health News from Medical News Today [2009.11.19]
Linkage Biosciences, Inc., a privately held molecular diagnostics company, recently unveiled LinkSeq™ -- a new one-step method for Human Leukocyte Antigen (HLA) testing -- at the annual meeting of the American Society of Histocompatibility and Immunogenetics (ASHI) in San Francisco.

ImmunoGen, Inc. Announces Encouraging Clinical Data With Its IMGN901 Compound In The Treatment Of Merkel Cell Carcinoma
Source: Cancer / Oncology News From Medical News Today [2009.11.18]
ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that develops targeted anticancer therapeutics, today reported encouraging clinical data with its IMGN901 product candidate in the treatment of Merkel cell carcinoma (MCC). Meaningful evidence of anticancer activity has been noted among the limited number of patients with MCC who have received IMGN901.

Effects Of Vitamin D Deficiency Amplified By Shortage Of Estrogen
Source: Endocrinology News From Medical News Today [2009.11.17]
Researchers at Johns Hopkins are reporting what is believed to be the first conclusive evidence in men that the long-term ill effects of vitamin D deficiency are amplified by lower levels of the key sex hormone estrogen, but not testosterone. In a national study in 1010 men, to be presented Nov.

ThromboGenics And BioInvent Complete Phase I Patient Trial Of Anti-PlGF Cancer Therapeutic TB-403 In Patients With Advanced Solid Tumours
Source: Pharma Industry / Biotech Industry News From Medical News Today [2009.11.17]
ThromboGenics NV (Euronext Brussels: THR) and BioInvent International AB (OMXS: BINV) announced positive results from a Phase I trial of their novel anti-cancer monoclonal antibody TB-403 in patients with advanced solid tumours. The results were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, U.S. TB-403 was well tolerated with no reported dose limiting toxicity.

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Published Studies Related to Ogen (Estropipate)

Suppression of the barley uroporphyrinogen III synthase gene by a Ds activation tagging element generates developmental photosensitivity. [2009.03]
Chlorophyll production involves the synthesis of photoreactive intermediates that, when in excess, are toxic due to the production of reactive oxygen species (ROS). A novel, activation-tagged barley (Hordeum vulgare) mutant is described that results from antisense suppression of a uroporphyrinogen III synthase (Uros) gene, the product of which catalyzes the sixth step in the synthesis of chlorophyll and heme.

Protective effects of plasmin(ogen) in a mouse model of Staphylococcus aureus-induced arthritis. [2008.03]
OBJECTIVE: To assess the functional roles of plasmin in a murine model of Staphylococcus aureus-induced bacterial arthritis... CONCLUSION: Our findings indicate that plasmin plays a pluripotent role in protecting against S aureus-induced arthritis by activating inflammatory cells, killing bacteria, removing necrotic tissue, and enhancing cytokine expression.

Fibrin(ogen) exacerbates inflammatory joint disease through a mechanism linked to the integrin alphaMbeta2 binding motif. [2007.11]
Fibrin deposition within joints is a prominent feature of arthritis, but the precise contribution of fibrin(ogen) to inflammatory events that cause debilitating joint damage remains unknown. To determine the importance of fibrin(ogen) in arthritis, gene-targeted mice either deficient in fibrinogen (Fib-) or expressing mutant forms of fibrinogen, lacking the leukocyte receptor integrin alphaMbeta2 binding motif (Fibgamma390-396A) or the alphaIIbbeta3 platelet integrin-binding motif (FibgammaDelta5), were challenged with collagen-induced arthritis (CIA)...

Combined administration of barbourin--albumin and hirudin--albumin fusion proteins limits fibrin(ogen) deposition on the rabbit balloon-injured aorta. [2007]
INTRODUCTION: There are continuing needs for new antithrombotic agents and procedures. We hypothesized that the slowly cleared recombinant fusion proteins barbourin--albumin (BLAH6) and hirudin--albumin (HLAH6) would be effective in limiting fibrin(ogen) and/or platelet deposition in a rabbit model of arterial injury... CONCLUSIONS: BLAH6 administration elicited a dose- and time-dependent inhibition of platelet aggregation in post-injection whole blood samples, and reduced both fibrin(ogen) and platelet deposition on the injured aorta, although the former effect was both more durable and more significant than the latter. In contrast, HLAH6 injection reduced fibrin(ogen) but not platelet deposition. Doses of the two proteins ineffective in preventing fibrin(ogen) deposition when given alone were effective when combined, suggesting at least additive effects. Immunohistochemistry and EM supported the radioactive deposition studies, while bleeding times were decreased with combined BLAH6 and HLAH6 administration compared to HLAH6 alone in a rabbit ear bleeding model. The data show that these fusion proteins exert an antithrombotic effect in vivo and may indicate that combined low-dose administration of antiplatelet and antithrombin agents could offer safety advantages in the treatment of thrombosis.

Turnover and fate of fibrinogen and platelets at the rabbit aorta wall immediately after a balloon de-endothelializing injury in vivo. [2006.07]
A de-endothelializing injury to the artery wall in vivo results in a rapid procoagulant response at the surface of the exposed subendothelium. Activated tissue factor (TF)-bearing cells and hemostasis factors located at the site of injury respond by producing thrombin, and within minutes the principal thrombus-forming, blood-borne components (platelets, fibrinogen) accumulate at the site...

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Clinical Trials Related to Ogen (Estropipate)

Phase 2a Randomized, Double-Blind Study of Oleoyl-Estrone in Male Morbidly Obese Adults [Active, not recruiting]

Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101) [Active, not recruiting]
The purpose of this study is to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day cycles of escalating oral doses of MP 101 in 100 obese adult subjects.

Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel [Recruiting]
The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex hormones, among women suffering from severe PreMenstrual Syndrome (PMS).

The system includes skin testing panel for identification of hormones to which the patients might be sensitive. Tests are applied close to the ovulation period and the skin reaction is examined in 20 minutes, 48 hours and daily during the following month. Results of skin tests and patient's history will determine the value of EVE-PMS Skin-Test Panel as a diagnostic tool for severe PMS patients.

Evaluation of Safety/Efficacy of Diagnostic Skin Test Panel and Desensitization Hormone Kit for Treatment of Premenstrual Syndrome (PMS) [Recruiting]
The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex hormones, among women suffering from severe PreMenstrual Syndrome (PMS) and desensitizes them with the relevant sex hormones in order to reduce PMS symptoms.

The system includes skin testing panel for identification of hormones to which the patients might be sensitive. Tests are applied close to the ovulation period and the skin reaction is examined in 20 minutes, 48 hours and daily during the following month. Results of skin tests and patient's history will determine the eligibility of the patients to enter a desensitization protocol.

During the desensitization period hormones to which the patient were found sensitive to, are injected intradermally three times (once a month) within the luteal phase in increasing doses. The end-point of the study is a statistically significant decrease, or elimination of PMS symptoms, compared to a solvent group.

A Study to Characterize Epidemiology, Clinical and Genetic Features of Kallmann Syndrome in Finland [Enrolling by invitation]

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