Theramex launches Lundeos® / Fedivelle®, a new colecalciferol small soft gel capsule for the treatment of Vitamin D deficiency

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Theramex launches Lundeos^® / Fedivelle^®, a new colecalciferol small soft gel capsule for the treatment of Vitamin D deficiency

London, 5 May 2021: Theramex has today launched Lundeos^® (colecalciferol) in Spain, and the launch of Fedivelle^® (colecalciferol) in Italy is expected in the coming weeks. Offering daily or weekly dosing (1,000 IU up to four times per day, or 20,000 IU weekly), Lundeos^® / Fedivelle^®  is a new, flexible presentation of colecalciferol, a Vitamin D3 treatment for adults and adolescents who are deficient, including women in different stages of their life, such as pregnancy, menopause, and osteoporosis.^1,2 It has been developed as a small soft gel capsule with the aim of improving convenience and making the treatment easy to take.^1,2

Recent large observational data suggests that 40% of Europeans are Vitamin D deficient and 13% are severely deficient.³ Vitamin D deficiency has been associated with greater incidence of hip fracture in many populations, including postmenopausal women.⁴ Observations from women with osteoporosis who were hospitalised due to hip fractures, found that 50% had signs of Vitamin D deficiency.⁴

Osteoporosis remains largely underdiagnosed and undertreated across Europe, resulting in a large number of fractures. Among the population aged over 50 years, one in three women will suffer a fragility fracture.⁵ Hip, spine and wrist fractures are the most common fractures, which have a debilitating impact on daily activities and quality of life.⁵

Robert Stewart, CEO of Theramex, commented:

“Theramex is dedicated to women’s health. Whether for care through pregnancy, menopause, osteoporosis, or for a healthy lifestyle, many women rely on Vitamin D for their wellbeing. In introducing a new Vitamin D to support women, we had three key criteria: It had to be colecalciferol as this is widely regarded as the leading Vitamin D formulation. It should be delivered in a simple, palatable and convenient method. And, there should be flexibility in dosing to suit the needs of women at different phases in their lives. The launch of Lundeos^® / Fedivelle^®, a Vitamin D supplement in the new format of a small soft gel capsule, available in daily or weekly dosages, meets these requirements and will expand the market so that more women are able to access this important therapy.”

Ends

About Lundeos^®/Fedeville^®

Lundeos^®/Fedeville^® is colecalciferol in a small soft gel capsule, making it convenient and easy to take.^1,2 It offers daily or weekly dosing: 1,000 IU capsule up to 4 times a day or 20,000 IU capsule weekly.^1,2 The 1,000 IU capsule is indicated to treat Vitamin D deficiency in adults and adolescents; to prevent Vitamin D deficiency in adults with an identified risk; and, as an adjunct therapy for adult osteoporosis patients with, or at risk of, Vitamin D deficiency.¹ The 20,000 IU capsule is indicated to treat clinically relevant Vitamin D deficiency in adults.²

About Theramex

Theramex is a leading, global speciality pharmaceutical company dedicated to women and their health. With a broad portfolio of innovative and established brands covering contraception, fertility, Menopause and Osteoporosis, we support women at every stage of their lives. Our commitment is to listen and understand our patients, serve their needs, and offer healthcare solutions to help improve their lives. Our vision is to be a lifetime partner for women and the healthcare professionals who treat them, by providing innovative and effective solutions that care for and support women as they advance through each stage of their lives.

Contacts:

Andrew Bradley, Head of Communications Theramex

andrew.bradley@theramex.com / +44 (0)7864 167962

Helen Rae, Makara Health

helenrae@makarahealth.com / +44(0)7503 652311

References

1. Theramex Ltd. Colecalciferol 1,000 IU SmPC
2. Theramex Ltd. Colecalciferol 20,000 IU SmPC
3. Cashman KD, et al. Vitamin D deficiency in Europe: pandemic? Am J Clin Nutr. 2016;103:1033–44.
4. LeBoff MS, et al. Occult vitamin D deficiency in postmenopausal US women with acute hip fracture. JAMA. 1999;251:1505–11
5. IOF Compendium of Osteoporosis. 25^th September 2019. osteoporosis.foundation/sites/iofbonehealth/files/2020-01/IOF-Compendium-of-Osteoporosis-web-V02.pdf Last accessed: April 2021