HETLIOZ™ (tasimelteon) Data in Patients with Non-24-Hour Sleep-Wake Disorder to be presented at SLEEP 2014 meeting

Jun 02, 2014, 19:00 ET from Vanda Pharmaceuticals Inc.

WASHINGTON, June 2, 2014 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) will present additional data from its HETLIOZ™ (tasimelteon) clinical development program at SLEEP 2014, the 28th Annual Meeting of Associated Professional Sleep Societies in Minneapolis, Minnesota.

HETLIOZTM data at SLEEP 2014 will be presented in one oral and six poster sessions. The data presentation schedule is as follows:

Oral Presentation

  • June 4th at 2:15 – 2:30pm, Assessment of clinical measures in Non-24 Disorder in Patients Entrained by Tasimelteon with Dr. Steven Lockley

Poster Presentations

  • June 2nd at 4 – 6pm
    • Poster 74  Evaluation of the effect of concomitant consumption of tasimelteon and ethanol on cognitive function, balance, and subjective measures in healthy subjects
  • June 4th at 10am12:20pm – Posters
    • 122 Causes of total blindness associated with Non-24-Hour Disorder
    • 124 Assessment of Potential for Withdrawal or Abuse with the use of the circadian regulator tasimelteon
    • 123 Tasimelteon a novel treatment for Non-24 Hour Disorder: Pooled safety analysis of two Phase II and two Phase III placebo controlled studies
    • 125 LQ-nTST, UQ-dTSD, and MoST: Circadian Specific Sleep/Wake Measures for Non-24 Patients
    • 126 Phase Analysis of nighttime total sleep time and daytime total sleep duration in patients with Non-24-Hour Disorder

About Non-24-Hour Sleep-Wake Disorder  Non-24 was first described more than 60 years ago, and is a chronic, circadian rhythm disorder resulting from the misalignment of the endogenous master body clock to the 24-hour day, disrupting the sleep-wake cycle. The sleep disturbance causes significant distress or impairment in social, occupational and other important areas of functioning. Non-24 affects the majority of totally blind individuals and it is estimated that approximately 80,000 Americans have the disorder.

About HETLIOZ™ HETLIOZ™ is a melatonin receptor agonist. HETLIOZ™ has been approved by the U.S. Food and Drug Administration for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).

Full HETLIOZ™ Prescribing Information can be found at: www.hetlioz.com.

For more information about HETLIOZ™ call 1-844-HETLIOZ (1-844-438-5469).

Indication and Important Safety Information About HETLIOZ™

Indication HETLIOZ™ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24).

Important Safety Information HETLIOZ™ may cause somnolence:  After taking HETLIOZ™, patients should limit their activity to preparing for going to bed, because HETLIOZ™ can impair the performance of activities requiring complete mental alertness.

The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ™ than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, upper respiratory or urinary tract infection.  The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ™ is increased by approximately 2-fold compared with younger patients.

Use of HETLIOZ™ should be avoided in combination with fluvoxamine or other strong CYP1A2 inhibitors, because of a potentially large increase in exposure of HETLIOZ™, and a greater risk of adverse reactions. HETLIOZ™ should be avoided in combination with rifampin or other CYP3A4 inducers, because of a potentially large decrease in exposure of HETLIOZ™, with reduced efficacy.

There are no adequate and well-controlled studies of HETLIOZ™ in pregnant women. Based on animal data, HETLIOZ™ may cause fetal harm.  HETLIOZ™ should be used during pregnancy only if the potential benefit justifies the potential risks.  Caution should be exercised when HETLIOZ™ is administered to a nursing woman.

HETLIOZ™ has not been studied in patients with severe hepatic impairment and is not recommended in these patients.

Safety and effectiveness of HETLIOZ™ in pediatric patients have not been established.

Full HETLIOZ™ Prescribing Information can be found at: www.hetlioz.com. 

About Vanda Pharmaceuticals Inc. Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders. For more on Vanda, please visit www.vandapharma.com.   

U.S. full prescribing information for HETLIOZ™ is available at www.HETLIOZ.com.

HETLIOZ™ is a registered trademark of Vanda Pharmaceuticals Inc.

Corporate Contact:

Jim Kelly Senior Vice President and Chief Financial Officer Vanda Pharmaceuticals Inc. (202) 734-3428 jim.kelly@vandapharma.com

Media Contact:

Laney Landsman Assistant Vice President Makovsky (212) 508-9643 llandsman@makovsky.com

SOURCE Vanda Pharmaceuticals Inc.