CHARLOTTE, N.C., Aug. 26, 2008 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension (NOH).
Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need. Fast Track designation allows a company to file a New Drug Application (NDA) on a rolling basis as data become available. This permits the FDA to review the filing as it is received, rather than waiting for the entire document prior to commencing the review process. In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review. A Priority Review generally reduces the time it takes the FDA to review a new drug application. The goal for completing a Priority Review is six months.
In addition to Fast Track designation, the FDA granted Droxidopa Orphan Drug status for the treatment of symptomatic neurogenic orthostatic hypotension and subsequently awarded Chelsea a Special Protocol Assessment (SPA) for the second of its pivotal studies in this program. An SPA provides a binding agreement that the study design, including trial size, clinical endpoints and/or data analyses is acceptable to support regulatory approval. Orphan Drug designation provides seven years of marketing exclusivity from the date of a drug's approval. In addition, user fees are waived and the sponsor is eligible for tax credits for clinical testing.
"The combination of Fast Track designation, Orphan Drug status and our SPA for Droxidopa positions Chelsea to maintain a close working relationship with the FDA to ensure that our clinical efforts are supportive of a successful regulatory approval process," commented Dr. Simon Pedder, President and CEO of Chelsea Therapeutics. "This Fast Track designation specifically acknowledges that despite the availability of an approved therapeutic in this indication, there remains a significant unmet medical need to alleviate the symptoms in patients suffering from neurogenic orthostatic hypotension. We remain focused on executing our ongoing Phase III program to facilitate the expeditious filing of a New Drug Application and obtaining the approvals required to make Droxidopa available to this underserved patient population."
About Droxidopa and Symptomatic Neurogenic Orthostatic Hypotension (NOH)
Symptomatic NOH is a neurogenic disorder resulting from a deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart. This deficiency results in decreased blood pressure when a person assumes a standing position and is characterized by lightheadedness, dizziness, blurred vision and syncope. Droxidopa, an orally active synthetic precursor of norepinephrine, increases the supply of norepinephrine available for delivery to its receptors to improve orthostatic blood pressure and alleviate symptoms of orthostatic hypotension.
In addition to creating significant health care costs, symptomatic NOH has a dramatic impact on a patient's quality of life. Given the chronic nature of symptomatic NOH and the proven safety and tolerability of Droxidopa, Chelsea expects that daily oral treatment with Droxidopa should provide a significant improvement in the long-term treatment of symptomatic NOH.
Droxidopa, developed by and licensed from Dainippon Sumitomo Pharma Co., Ltd. (DSP), initially received Japanese approval in 1989 for the treatment of frozen gait and dizziness on standing associated with Parkinson's Disease and for the treatment of orthostatic hypotension, syncope or dizziness on standing associated with Shy-Drager syndrome and Familial Amyloidotic Polyneuropathy. In 2000, Droxidopa received expanded marketing approval to include prevention of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients.
About Chelsea Therapeutics
Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. The Company is currently developing a library of metabolically inert antifolate compounds engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders. Early clinical data suggests that Chelsea's lead antifolate compound, CH-1504, is a safe and effective treatment alternative to methotrexate for RA and may have further applications for psoriasis, IBD and certain cancers. Chelsea's antifolate program is complemented by the development of the I-3D portfolio of therapeutics targeting immune-mediated inflammatory disorders and transplantation. In addition to its autoimmune pipeline, Chelsea is developing Droxidopa, an orally active synthetic precursor of norepinephrine, for the treatment of neurogenic orthostatic hypotension. Currently approved and marketed in Japan, Droxidopa has accumulated over 15 years of proven safety and efficacy, historically generating annual revenues of approximately $50 million in Japan.
This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include reliance on collaborations and licenses, risks and costs of drug development, regulatory approvals, intellectual property risks, our reliance on our lead drug candidate CH-1504, our history of losses and need to raise more money, competition, market acceptance for our products if any are approved for marketing, reliance on key personnel including specifically Dr. Pedder, management of rapid growth, and the need to acquire or develop additional products.