- The design of Vanda's primary Phase III study changed numerous times, including a complete replacement of the primary endpoint just one month before study results were announced.
- The replacement primary endpoint installed to assess Tasimelteon's benefit was created by Vanda and has never been used before in sleep-drug clinical trials, nor was it endorsed by the FDA.
- Vanda was forced to cut in half the patient enrollment into the Tasimelteon clinical trials because totally blind patients with non-24 could not be identified. Even then, Vanda was only able to enroll patients by stretching the clinical definition of non-24.
- Tasimelteon was only able to demonstrate a benefit for non-24 patients by combining data from two phase III studies. Despite Vanda's claims to the contrary, the phase III studies may have actually failed on their own.
Shareholder law firm Finkelstein Thompson LLP is investigating potential claims on behalf of shareholders of Vanda Pharmaceuticals, Inc. (“Vanda” or “the Company”) (NASDAQ: VNDA). If you are interested in discussing your rights as a Vanda shareholder, or have information relating to this investigation, please contact Finkelstein Thompson's Washington, DC offices at (877) 337-1050 or by email at firstname.lastname@example.org. Vanda is currently developing the drug Tasimelteon for treatment of non-24-hour disorder (“non-24”), a circadian rhythm disorder in which the patients’ internal “body clock” is misaligned, causing sleep irregularities. In late May 2013, the Company submitted a new drug approval application for Tasimelteon to the FDA. However, on June 19, 2013, thestreet.com published an article alleging several irregularities in the clinical trial process, including: