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droxidopa is an older drug that has been in clinical use in Japan since 1989. It's been in clinical trials in the US since 2007. Finally it seems it might become available in the U.S. Here's the long saga of the FDA's approval-- from Parkinson Pipeline Project database. (and note :this was a "fast track" drug approval) "In January 2007, U.S. Food and Drug Administration granted Orphan Drug designation to Chelsea Pharm. for Droxidopa for the "treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with Primary Autonomic Failure, a group of diseases that includes Parkinson's Disease, Pure Autonomic Failure (PAF) and Multiple Systems Atrophy (MSA). The Orphan Drug Act provides for economic incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the United States. Orphan Drug designation will entitle Chelsea to seven years of market exclusivity for Droxidopa in the treatment of symptomatic NOH. Additional benefits include tax credits related to clinical trial expenses, a possible exemption from the FDA-user fee, and assistance in clinical trial protocol design." (company press release) In August 2007, Chelsea Therapeutics International received orphan-drug status from the European Commission for the treatment of hypotension in PD. In the European Union, the designation provides 10 years of market exclusivity upon receipt of regulatory approval. In 2008, Chelsea also received the FDA's Fast Track designation, and 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. " (company press release) In June 2010 Chelsea announced they have "successfully reached the target enrollment of 150 patients in its Northera� (Droxidopa) pivotal Phase III Study 301 for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH). Results from the trial are expected in September 2010 and the full registration program is on track to initiate a new drug application (NDA) in the first half of 2011." In Dec. 2011, the sponsor announced it will be launched in the US in 2012 Why were five years of additional clinical trials necessary, when the drug has been used safely and successfully in Japan sice 1989? linda www.pdpipeline.org ---------- Original Message ---------- From: mschild <[log in to unmask]> To: [log in to unmask] Subject: Re: droxidopa - new drug for PD Date: Sat, 31 Dec 2011 10:09:27 +0100 does not seem very new to me: http://chelseatherapeutics.com/pipeline/droxidopa/droxidopa.html they must be recycling Droxidopa Droxidopa is an orally active synthetic precursor of norepinephrine currently approved and marketed in Japan for the treatment of orthostatic hypotension. By replenishing depleted norepinephrine via endogenous enzymatic pathway, Droxidopa allows for re-uptake of norepinephrine into peripheral nervous system neurons � stimulating receptors for vasoconstrinction and providing physiological improvement in symptomatic neurogenic orthostatic hypotension patients. With over 15 years of proven safety and efficacy in its target indications, Droxidopa provides a unique opportunity to accelerate Chelsea's drug development activities, expand its product pipeline and help finance the establishment of a sales and marketing infrastructure prior to commercialization of the company�s other compounds including CH-1504. Originally approved in 1989 for the treatment of frozen gait or dizziness associated with Parkinson's Disease and for the treatment of orthostatic hypotension, syncope or dizziness associated with Shy-Drager syndrome and Familial Amyloidotic Polyneuropathy, DSP expanded marketing approval in 2000 to include treatment of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients. ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn