Endo Pharmaceuticals Completes Next Step in Regulatory Process for FORTESTA(TM) for Men With Low Testosterone
CHADDS FORD, Pa., July 1 /PRNewswire-FirstCall/ — Endo Pharmaceuticals (Nasdaq: ENDP) has submitted a complete response to the U.S. Food and Drug Administration (FDA) following the company’s receipt of a Complete Response letter in October 2009 related to the New Drug Application (NDA) submission for FORTESTA(TM) (testosterone) 2% gel. The company’s Class 2 resubmission is the next step in its intention to offer FORTESTA as a treatment option in the United States for men diagnosed with low testosterone (Low T), also known as hypogonadism. The FDA’s review period for Class 2 resubmissions typically is six months.
“We are optimistic that our expeditious and careful response to the FDA’s requests will lead to the agency’s approval of FORTESTA,” said Julie McHugh, chief operating officer, Endo Pharmaceuticals. “We are committed to making this testosterone gel formula available as soon as possible and will continue to work closely with the FDA toward our goal of making this product available for the treatment of low testosterone in men.”
ProStrakan Group plc submitted the NDA for FORTESTA to the FDA in April 2009, and Endo signed an agreement with ProStrakan in August 2009 to acquire exclusive U.S. rights to commercialize the testosterone 2% gel, branded variously as Tostran, Tostrex and Itnogen outside of the U.S. The principal content of the re-submission is a re-analysis of the primary variable (testosterone levels) in the original pivotal study. This re-analysis has confirmed the reliability of the original conclusions of the study. In addition, Endo has provided information in the Complete Response about its plans for a post-approval “hand-wash” study.
Low T, also known as hypogonadism, is a condition in men characterized by the body’s failure to produce normal amounts of the hormone testosterone. It is associated with symptoms including decreased energy and mood, fatigue, loss of muscle mass, decreased libido and erectile dysfunction. Because the symptoms of Low T are often similar to those caused by other medical conditions, more than 91 percent of men with the condition go undiagnosed.
Endo Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development, sale and marketing of branded and generic prescription pharmaceuticals used to treat and manage pain, prostate cancer, bladder cancer and the early onset of puberty in children, or central precocious puberty (CPP). Its products include LIDODERMÃ‚®, a topical patch to relieve the pain of postherpetic neuralgia; PercocetÃ‚® and PercodanÃ‚® tablets for the relief of moderate-to-moderately severe pain; FROVAÃ‚® tablets for the acute treatment of migraine attacks with or without aura in adults; OPANAÃ‚® tablets for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate; OPANAÃ‚® ER tablets for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time; VoltarenÃ‚® Gel, which is owned and licensed by Novartis AG, a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as those of the hands and the knees; VANTASÃ‚® for the palliative treatment of advanced prostate cancer; SUPPRELINÃ‚® LA for the treatment of early onset puberty in children; and VALSTARÃ‚® for the treatment of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable medical risks. The company markets its branded pharmaceutical products to physicians in pain management, urology, endocrinology, oncology, neurology, surgery and primary care. More information, including this and past press releases of Endo Pharmaceuticals, is available at www.endo.com.
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SOURCE Endo Pharmaceuticals