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Back To Vidyya FDA Approves Orapred®

Gives Doctors New Option for Children with Asthma

Ascent Pediatrics, Inc. announced today that it has received approval from the U.S. Food and Drug Administration to market Orapred(R) (prednisolone sodium phosphate 20.2mg/5mL, equivalent to prednisolone 15mg/5mL) oral solution as a treatment for children with asthma and other inflammatory conditions. The company expects Orapred, which is available only by prescription, to begin shipping to pharmacies in January.

Asthma is the number one reason that children under the age of 14 are hospitalized each year, accounting for 12 to 17 percent of all discharge diagnoses. According to the National Institute of Allergy and Infectious Disease, asthma is the most common chronic disease of childhood, affecting nearly five million children in the United States.

In terms of treatment, liquid corticosteroids are commonly prescribed for acute asthma attacks in children, while inhaled steroids are commonly prescribed as maintenance therapy. A recent study published in The New England Journal of Medicine showed that liquid corticosteroids are more effective than inhaled corticosteroids in treating acute asthma in children. Orapred was not included in the study, as it was conducted prior to FDA approval.

"Currently available liquid corticosteroids have a very bitter and objectionable taste. Through its proprietary taste-masking technology and its pleasant grape-flavor, Orapred offers pediatricians the liquid steroid strength they prefer and the taste children prefer," said Emmett Clemente, Ph.D., president and chairman of Ascent Pediatrics. "We believe it will ease the struggle that many parents have in forcing a child to take a liquid corticosteroid."

Nearly 90 percent of pediatricians surveyed by Ascent indicate that Prelone(R), the most often prescribed liquid corticosteroid, tastes bad, and more than half believe that its taste has prevented their patients from getting better quickly because they refuse to take the medication. A taste-preference study conducted by Ascent shows that 70 percent of children prefer the taste of Orapred to Prelone.

According to a recent editorial in the Journal of Pediatrics by Miles Weinberger, M.D., professor of pediatrics at the University of Iowa Hospital, "Both (Pediapred(R) and Prelone) are bitter, rather foul-tasting, and have a nasty aftertaste ... Because of the problems with oral tolerance of currently available liquid formulations, there is a critical need for an adequately concentrated palatable liquid."

"Before Orapred(R), pediatricians had a difficult choice to make -- either prescribe an oral corticosteroid in an optimal strength, knowing that the patient may not take it due to its objectionable taste, or prescribe one that tasted slightly better in a weaker strength, knowing the patient would have to take a lot more of it," said Elliot Ellis, M.D., former president of the American Academy of Allergy, Asthma and Immunology. "With Orapred, because of its better taste, it is reassuring to know that the children will get the dose they need without a struggle."

As with all liquid corticosteroids, Orapred is not recommended for persons with systemic fungal infections. Potential side effects include dermatologic and gastrointestinal disturbances. Orapred is available by prescription only.

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Editor: Susan K. Boyer, RN
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