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Filed Pursuant to Rule 424(b)(3)
Registration No. 333-23319
ASCENT PEDIATRICS, INC.
SUPPLEMENT DATED JUNE 19, 1997
TO PROSPECTUS DATED
MAY 29, 1997
Ascent Pediatrics, Inc. ("Ascent" or the "Company") has received United
States Food and Drug Administration (the "FDA") approval of the Company's new
drug application ("NDA") for the use of Ascent's first formulation of Primsol
Solution (trimethoprim hydrochloride oral solution) for the treatment of acute
otitis media (middle ear infection) in children age 6 months to 12 years.
At the time that the FDA notified Ascent of the approval, a member of the
staff of the FDA stated to Ascent by telephone that the FDA was preparing a list
of questions concerning Ascent's second NDA filing covering a more concentrated
formulation of Primsol Solution and was considering requiring Ascent to conduct
a bioavailability study comparing this more concentrated formulation with the
approved Primsol Solution formulation. If the Company determines that the FDA is
not moving towards approval of the Company's NDA covering the more concentrated
formulation of Primsol Solution on an expeditious basis, the Company plans to
introduce the approved formulation of this product as the Primsol Solution that
it first brings to market.
Ascent also has received a letter from the FDA notifying Ascent that the
FDA would not accept for filing Ascent's abbreviated new drug application for
Prednisolone Sodium Phosphate Syrup. In its letter, the FDA stated that it was
unclear from the information provided whether one inactive ingredient used in
this product had been the subject of an approved new or abbreviated drug
application and that the amount of a second inactive ingredient used in the
product exceeded the amount previously approved in a drug product. One of these
ingredients is a sugar and the second is a flavoring agent; both are included in
the product for taste-masking purposes. The FDA requested that Ascent justify
that the changes in its product from the reference listed drug do not affect the
safety or absorption of Ascent's product.
The Company believes that the first of the two inactive ingredients (the
sugar) in its Prednisolone product is used as an ingredient in a number of
prescription and over-the-counter drug and food products, that the amount of the
second inactive ingredient (the flavoring agent) is less than the amount used in
many food products and that this second ingredient appears on the FDA's list of
ingredients that are designated generally recognized as safe (GRAS). The Company
is in the process of preparing a written submission in response to the FDA
letter. There can be no assurance that the Company will not be required to
demonstrate to the FDA that the inactive ingredients in its Prednisolone product
do not adversely affect the safety and effectiveness of the active ingredients.
