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Tuesday, December 18, 2012 9:00:41 AM
VNDA +20% Vanda Announces Positive Phase III Results For Tasimelteon In The Treatment Of Non-24-Hour Disorder
Today : Tuesday 18 December 2012
WASHINGTON, Dec. 18, 2012 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) today announced positive results from the SET (Safety and Efficacy of Tasimelteon) Phase III study, evaluating tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24). Tasimelteon succeeded in the primary endpoint of Entrainment of the melatonin (aMT6s) rhythm as compared to placebo.
Additionally, tasimelteon demonstrated significant improvements across a number of sleep and wake parameters including measures of total sleep time, nap duration, and timing of sleep. Tasimelteon also showed significant improvements over placebo in the Non-24 Clinical Response Scale (N24CRS) as well as in the Clinical Global Impression of Change (CGI-C), an overall global functioning scale. These results provide robust evidence of a direct and clinically meaningful benefit to patients with Non-24.
Non-24 is a serious, rare circadian rhythm disorder that affects a majority of totally blind individuals who lack light perception and cannot entrain (reset) their master body clock to the 24-hour day. Currently there is no approved treatment for Non-24.
"Today's results confirm tasimelteon as a strong circadian regulator capable of entraining the master body clock in patients with Non-24. We are particularly impressed and excited by the magnitude and robustness of the direct clinical benefits to patients," said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda. "We believe that tasimelteon can be an effective and clinically meaningful treatment for patients suffering with this debilitating disorder."
"As a person who regularly experiences the debilitating symptoms of Non-24, these findings are important to me and I think they are important to the blind community as a whole, because they give us hope that a potential new treatment approach is on the horizon," said Melanie Brunson, Executive Director of the American Council of the Blind.
Primary Endpoints
The SET study was an 84 patient randomized, double-masked, placebo-controlled study in patients with Non-24. The primary endpoints for this study were Entrainment of the melatonin (aMT6s) rhythm to the 24-hour clock and Clinical Response as measured by Entrainment plus a score of greater than or equal to 3 on N24CRS.
http://ih.advfn.com/p.php?pid=nmona&article=55506759
Today : Tuesday 18 December 2012
WASHINGTON, Dec. 18, 2012 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) today announced positive results from the SET (Safety and Efficacy of Tasimelteon) Phase III study, evaluating tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24). Tasimelteon succeeded in the primary endpoint of Entrainment of the melatonin (aMT6s) rhythm as compared to placebo.
Additionally, tasimelteon demonstrated significant improvements across a number of sleep and wake parameters including measures of total sleep time, nap duration, and timing of sleep. Tasimelteon also showed significant improvements over placebo in the Non-24 Clinical Response Scale (N24CRS) as well as in the Clinical Global Impression of Change (CGI-C), an overall global functioning scale. These results provide robust evidence of a direct and clinically meaningful benefit to patients with Non-24.
Non-24 is a serious, rare circadian rhythm disorder that affects a majority of totally blind individuals who lack light perception and cannot entrain (reset) their master body clock to the 24-hour day. Currently there is no approved treatment for Non-24.
"Today's results confirm tasimelteon as a strong circadian regulator capable of entraining the master body clock in patients with Non-24. We are particularly impressed and excited by the magnitude and robustness of the direct clinical benefits to patients," said Mihael H. Polymeropoulos, M.D., President and CEO of Vanda. "We believe that tasimelteon can be an effective and clinically meaningful treatment for patients suffering with this debilitating disorder."
"As a person who regularly experiences the debilitating symptoms of Non-24, these findings are important to me and I think they are important to the blind community as a whole, because they give us hope that a potential new treatment approach is on the horizon," said Melanie Brunson, Executive Director of the American Council of the Blind.
Primary Endpoints
The SET study was an 84 patient randomized, double-masked, placebo-controlled study in patients with Non-24. The primary endpoints for this study were Entrainment of the melatonin (aMT6s) rhythm to the 24-hour clock and Clinical Response as measured by Entrainment plus a score of greater than or equal to 3 on N24CRS.
http://ih.advfn.com/p.php?pid=nmona&article=55506759
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