Avion Pharmaceuticals, LLC, a specialty pharmaceutical company, has announced a license and commercialization agreement with Aspen Pharma USA Inc. and Aspen Global Incorporated, both wholly owned subsidiaries of Aspen Pharmacare Holdings Limited, for the exclusive rights to relaunch Cenestin® (synthetic conjugated estrogens, A) tablet, the only plant-derived mixture of 9 conjugated estrogens indicated for treatment of moderate to severe vasomotor symptoms and moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Cenestin® tablets will be available in 0.3 mg, 0.45 mg, 0.625 mg, 0.9 mg and 1.25 mg strengths of synthetic conjugated estrogens.1
Vasomotor symptoms are prevalent in approximately 40 to 50 million women in the United States with approximately 1.3 million women becoming menopausal each year.2,3 With the relaunch of Cenestin®, millions of menopausal women will have a plant-derived choice in conjugated estrogens products for the treatment of vasomotor symptoms associated with menopause.
Cenestin® showed significant reduction in moderate to severe vasomotor symptoms at weeks 4, 8 and 12 as compared to placebo in a double-blind, placebo-controlled, randomized 12-week clinical trial of 120 postmenopausal women. Cenestin® significantly decreased the mean vaginal pH from baseline as compared to placebo in a 16-week, randomized, placebo-controlled, multicenter clinical study in 72 postmenopausal women. Cenestin® was observed to be well tolerated, safe and effective in both clinical studies.
“Avion Pharmaceuticals has been diligent and focused in supporting our patients and prescribing partners in Women’s Health for more than 9 years with our portfolio of prescription nutritional supplements and oral contraceptives,” stated Art Deas, CEO of Avion Pharmaceuticals. “Cenestin® will allow us to expand our commitment to women who are seeking options to manage their menopause journey and allow for effective symptom management. We are honored to support women throughout their life with their important health-related needs and milestones they encounter,” added Deas.
“Avion’s expertise and success in Women’s Health provides the perfect partnership to relaunch Cenestin®,” stated Stephen Saad, Aspen Group Chief Executive. “Cenestin will provide an effective alternative to millions of menopausal women, with a preference for a plant derived conjugated estrogen, to manage the symptoms of menopause, Avion is ideally positioned having the necessary technical and commercial resources to execute the relaunch of the Cenestin NDA. This agreement is a further step towards increasing our presence in the United States leveraging our niche global intellectual property.”
About Avion Pharmaceuticals, LLC
Avion Pharmaceuticals, LLC is a specialty pharmaceutical company formed to develop, acquire and market a portfolio of innovative pharmaceutical products in the Women’s Health and other therapeutic categories aligned with our mission to improve the quality of patient lives. Avion Pharmaceuticals focuses on identifying opportunities to develop, acquire and enhance the market potential of innovative, commercially available therapeutics and late-stage development drugs to fulfill unmet medical needs. For additional information about Avion Pharmaceuticals please contact the company at 678-325-5188. For more information, visit www.avionrx.com.
Headquartered in Durban, South Africa, Aspen is a global specialty and branded multinational pharmaceutical company with a commercial presence in both emerging and developed markets.
With a 160-year heritage, we improve the health of patients in more than 150 countries with our high quality, affordable products. The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals comprising Regional Brands and Sterile Focus Brands that include Anesthetics and Thrombosis products. For further information visit www.aspenpharma.com.
REFERENCES: 1.https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020992s034lbl.pdf 2. Utian, Wulf H. “Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review.” Health and Quality of Life outcomes 3.1 (2005): 47. https://www.amjmed.com/article/S0002-9343(05)00885-5/fulltext 3. Menopause and Mood Disorders: Overview, Pathophysiology… emedicine.medscape.com › article › 295382-overview. https://emedicine.medscape.com/article/295382-overview