Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) eagerly waiting for FDA decision


Dallas, Texas 01/06/2014 (FINANCIALSTRENDS) – Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) along with three other major pharmaceutical companies has been waiting for Food and Drug Administration (FDA) and Panel meetings to be completed in due course to commercially bring out their patent-driven medicines. This includes-Aveo Pharmaceuticals drug Tivozanib, Amarin Corporatoins-Vascepa, Vanda Pharmaceuticals- Tasimelteon, a drug for treating complete blindness and known by the name of Non-24 disorder.

Chelsea Therapeutics International Ltd. (NASDAQ:CHTP)’s drug is the Droxidopa, or the orphan drug Northera, which was developed to treat symptomatic neurgenic hypotension or NOH, a symptom of Parkinsons. The FDA had in 2007, orphan drug status, followed by 2011 priority review and in Feb 2012, Panel meeting endorsement. However, in March 2012, FDA sought more data to resolve efficacy issues and durability.

FDA wanted Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) to work more on its 306B trial and nearly a year later in Feb 2013, FDA assured CHTP that it could on the basis of its 306B trials represent the drug before it.

The issue that the re-run of the 306B trials helped establish was that the – dizziness control in the patient on this drug – was considerably better.

Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) is also now under review by the FDA for Phase 2 Intradialytic Hypotension as well as Fibromyalgia. On the stock market front the company had been seeing much upgrade in post-November season. However on in the first week of January, issues with Feuerstein markings, in TheStreet column, Biotech Stock Mailbag, leading to slide downwards of 10% to 12% by Friday end of closing day.

As CHTP heads into Jan 14, 2014, panel meeting, Northera data is apparently not headed in the same direction, resulting in yet another FDA hold-up for this drug with  a long clinical –trial history thus far.