Roberts Pharmaceutical Corporation Reports Phase III Data Indicate Strong Analgesic Potency of Dirame(R)

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Roberts Pharmaceutical Corporation Reports Phase III Data Indicate Strong Analgesic Potency of Dirame(R)
    EATONTOWN, N.J., March 16 /PRNewswire/ -- Roberts Pharmaceutical
Corporation (Amex: RPC) today announced that a preliminary review of data from
a Phase III post-operative dental pain study indicate strong analgesic potency
for Dirame (propiram).
    Dirame is an orally administered, centrally acting, mu opioid receptor
agonist/antagonist being developed by Roberts for the treatment of moderate to
severe pain.  Phase III clinical trials of the compound involve ongoing
osteoarthritis and the now completed post-operative dental pain model.
Roberts said these models are reliable indicators of analgesic effects.
    This recently concluded post-operative pain study involved 350 patients
with extractions of 2 or more third molars.  The clinical trial was designed
as a single-dose, randomized, double blind, and placebo-controlled study of
Dirame at 25mg, 50mg, 100mg and 150mg.  The study also included, as an active
comparator, 100mg Ultram(R) (tramadol), the maximum recommended single-dose
for this approved and market leading opioid analgesic.  Primary endpoints
focused on differences in pain intensity from baseline over a period of
several hours.
    The results of these studies demonstrated that Dirame produced significant
analgesic effect at doses of 50mg and above.  Moreover, at the 50mg and higher
doses, Dirame's efficacy proved to be statistically significant in comparison
to 100mg tramadol as well as placebo.
    David S. Tierney, M.D., Roberts' Senior Vice-President of Drug Development
said, "Pain is still not particularly well managed and there is increasing
acceptance within the medical community that many patients are suffering
unnecessarily.  This creates a significant opportunity for a new drug that can
demonstrate advantages over existing products.  To date, the clinical evidence
regarding the analgesic potency of Dirame has been very encouraging."
John T. Spitznagel, Roberts' President and CEO said, "Dirame represents the
first of our next generation products.  We are all very excited about its
future prospects given the importance and substantial size of the analgesic
market and the fact that Roberts owns worldwide rights to this compound."
Mr. Spitznagel concluded by saying, "Later this year we expect to have data
from Phase III studies in the osteoarthritis model.  If that data support the
results observed in the post-operative model, Dirame, upon approval, could
represent a larger potential for Roberts than first thought."
    Roberts Pharmaceutical Corporation, with operating subsidiaries in the
United States, Canada and the United Kingdom, focuses on value-added specialty
pharmaceuticals in the therapeutic categories of gastroenterology, urology,
oncology/hematology, and cardiology/neurology.   Roberts actively pursues its
strategy of Search & Develop to identify and acquire novel post-discovery drug
candidates to advance through late-stage clinical development while also
pursuing opportunities to acquire and enhance the potential of commercially
available specialty medicines.
    This and past press releases of Roberts Pharmaceutical Corporation are
available through the Internet at the Roberts' home page at
http://www.robertspharm.com.
    This release contains forward looking statements which are based on
assumptions and external factors, including assumptions relating to, but not
limited to regulatory action, product pricing, competitive market conditions,
unaudited financial data, new product development and other risks or
uncertainties detailed from time to time in Roberts filings with the
Securities and Exchange Commission.  These forward-looking statements
represent the Company's judgment as of the date of this release and any
changes in the assumptions or external factors could produce significantly
different results.  With regard to new drugs in the development pipeline, the
timing and satisfactory completion of clinical trials, the establishment of
safety and efficacy, and the successful filing of New Drug Applications and
approval of those Applications by regulatory authorities are always subject to
risks and cannot be guaranteed.
SOURCE Roberts Pharmaceutical Corporation
http://www.robertspharm.com
CONTACT:
Janet Browning of Roberts Pharmaceutical
Corporation, 732-676-1200, ext. 3077