PHARMACY

Study: Children with autism may benefit from hyperbaric therapy

BY Alaric DeArment

MELBOURNE, Fla. Children with autism may benefit from time spent in a hyperbaric chamber, according to a new study.

The randomized, controlled and double-blind study, published in the journal BMC Pediatrics and titled “Hyperbaric treatment for children with autism,” found that children who were placed in an OxyHealth portable hyperbaric chamber and breathed 24% oxygen at a pressure 1.3 times that of the atmosphere for 40 hourly sessions had significant improvements in overall functioning, social interaction and other areas, compared with children who received slightly pressurized room air.

“In our study, we observed significant improvements in several core autistic behaviors with the use of hyperbaric therapy at [1.3 atmospheres] compared to children receiving near-placebo treatment,” physician and lead study author Daniel Rossignol said in a statement. “These findings confirm what we are seeing in clinical practice – that many children with autism may benefit with the use of this treatment.”

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FDA approves third Depakote generic

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved a generic version of a drug used to treat epilepsy.

The agency approved Mylan’s divalproex sodium delayed-release tablets in the 125 mg, 250 mg and 500 mg strengths. The tablets are a generic version of Abbott Labs’ Depakote, used to treat seizures and convulsions.

Mylan’s generic of Depakote is the third approved this month.

Depakote had sales of $803 million during the 12 months ending in March 2008, according to IMS Health data.

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FDA approves phase 3 study for autism treatment

BY Alaric DeArment

RYE, N.Y. The Food and Drug Administration has allowed a phase 3 study of a drug for autism to commence.

Curemark announced Wednesday that it expected to begin the trials of the drug CM-AT at multiple sites across the United States during second quarter 2009.

“With one-in-150 children diagnosed with autism, we have children who are suffering, Curemark CEO Joan Fallon said in a statement. “We are very excited about the opportunity to enter a phase 3 trial for this ever-growing population of children.”

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