Endo: FDA Oks AVEED Injection For Treatment Of Adult Men With Hypogonadism

By RTT News, March 06, 2014, 07:29:00 AM EDT

(RTTNews.com) - Endo International plc. (ENDP, ENL.TO) announced that its operating company Endo Pharmaceuticals Inc. received U.S. Food and Drug Administration or FDA approval of AVEED (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone.

The company stated that AVEED is a new prescription medicine indicated to produce serum testosterone levels in the normal range by administration of a single 3-mL (750 mg) intramuscular injection given once at initiation of therapy, at 4 weeks, and then every 10 weeks thereafter. It is expected to be available in early March.

The approval of AVEED is based on data from an 84-week Phase 3 trial of hypogonadal men in the U.S.Men enrolled in the study had an average age of 54 years and a serum total testosterone level of less than 300 ng/dL.

According to the company, AVEED is available as a single-use vial. Dosage titration is not necessary. Following the first intramuscular injection of 3 mL of AVEED (750 mg), a second 3 mL dose is injected 4 weeks later, and then 3 mL is injected every 10 weeks thereafter. AVEED is prescribed and administered by trained healthcare providers in a doctor's office, clinic, or hospital.

AVEED contains testosterone undecanoate, which Endo licensed through its subsidiary Endo Pharmaceuticals Solutions Inc. from Bayer Pharma AG. Outside the U.S., Bayer Pharma AG and its subsidiaries have been marketing testosterone undecanoate injections since 2003.

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Endo: FDA Oks AVEED Injection For Treatment Of Adult Men With Hypogonadism

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