FDA clears first drug for blindness sleep disorder

U.S. health regulators have approved a first-of-a-kind drug to treat a sleep disorder that mainly afflicts the blind.

The Food and Drug Administration approved Hetlioz capsules for patients who have problems sleeping because they can't detect light. The condition, called non-24-hour disorder, is estimated to affect up to 100,000 Americans, most of whom are totally blind. Hetlioz is the first FDA-approved treatment for the condition.

The most common side effects of the drug include headache, nightmares and respiratory and . The drug labeling warns that Hetlioz causes drowsiness and can interfere with performing basic tasks and mental alertness.

Analysts estimate the drug's annual sales could exceed $350 million.

Washington DC-based Vanda Pharmaceuticals markets one other drug for schizophrenia.

Company shares rose nearly 5 percent in afternoon trading.

5 /5 (1 vote)
add to favorites email to friend print save as pdf

Related Stories

US health watchdog rejects Sanofi's MS drug

Dec 30, 2013

French drug giant Sanofi announced Monday US health authorities had rejected its Lemtrada drug for some forms of multiple sclerosis, which is already approved in the European Union, Canada and Australia.

Recommended for you

Determine patient preferences by means of conjoint analysis

5 hours ago

The Conjoint Analysis (CA) method is in principle suitable to find out which preferences patients have regarding treatment goals. However, to widely use it in health economic evaluations, some (primarily methodological) issues ...

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

Tough-to-abuse formulation of oxycodone approved

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe pain when other ...

User comments