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
"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
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.