First drug for Charlotte-based Chelsea Therapeutics wins FDA approval

02/24/2014 11:00 AM

02/25/2014 3:26 AM

A Charlotte-based pharmaceutical company has received approval from the U.S. Food and Drug Administration to market its first drug, Northera, for treatment of a type of low blood pressure that can affect people with Parkinson’s disease and other neurological disorders.

Officials of Chelsea Therapeutics, located in Ballantyne office park, said they’ve been working toward approval of the drug since 2006 when they obtained a license from the drug’s owner, Dainippon Sumitomo, a large pharmaceutical company in Japan.

Northera will be used to treat patients with a rare disorder, neurogenic orthostatic hypotension, which causes dizziness and fainting.

The drug, also known by the generic name droxidopa, has been on the market in Japan since 1989. Chelsea sponsored clinical trials that led to FDA approval of the drug last week. The next step is to begin manufacturing in the United States and Canada and hiring people to market the drug to health care providers.

“The work really starts now with getting it on the market,” said Joseph Oliveto, president and chief executive officer of Chelsea Therapeutics. “Our goal is to get it on the market in the second half of this year.”

The FDA granted accelerated, or conditional, approval of Northera as a drug that fills a “serious unmet medical need,” according to the company’s announcement. For now, effectiveness beyond two weeks of treatment has not been demonstrated. As part of the approval, Chelsea will conduct another clinical trial with about 1,400 patients to assess the drug’s long-term benefits.

Mark Stacy, professor of neurology at Duke University School of Medicine, said the approval of Northera was “exciting news” because the low blood pressure problem in patients with Parkinson’s is difficult to treat.

He said he can prescribe other drugs to help manage patients’ muscle control, but “if their blood pressure drops to zero when they stand up, they’re still not going to be able to walk. ... This gives us a little bit better chance to get people moving.”

Stacy was a paid consultant to Chelsea until 2012 and enrolled patients in earlier clinical trials. “This is an agent that is sorely needed.”

Of the 1 million patients with Parkinson’s, about 5 percent to 10 percent will develop neurogenic orthostatic hypotension, Stacy said. In other patients with Parkinson-like syndromes, the low blood pressure symptoms are even more common.

Northera is a so-called “orphan” drug, the term for a drug developed specifically to treat a rare medical condition. About 80,000 to 150,000 U.S. patients are diagnosed with neurogenic orthostatic hypotension.

The FDA provides incentives to encourage development of orphan drugs that would otherwise not provide sufficient profit motive for companies. Oliveto said Chelsea benefits because it doesn’t have to pay certain FDA fees required for non-orphan drugs, didn’t have to enroll as many patients in the early clinical trials, and will get “market exclusivity” to sell Northera for seven years .

Chelsea was founded in 2004 by Simon Pedder, who resigned as president and CEO in 2012 during a cost-cutting reorganization. Oliveto succeeded him. Today, the company has 20 employees in Charlotte. Its stock is publicly traded on the Nasdaq as CHTP.

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