Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that it
plans to advance oral methylnaltrexone for the treatment of
opioid-induced constipation (OIC) into late stage clinical development
and will commence a phase 2b/3 clinical trial of a methylnaltrexone
tablet in chronic-pain patients in the second half of 2010. Progenics
also announced data from a clinical trial of this methylnaltrexone
tablet.
“We believe that the activity demonstrated to date by the
methylnaltrexone tablet shares the hallmarks of methylnaltrexone: both a
prompt onset of action and a predictable response for a large percentage
of patients”
The tablet form of oral methylnaltrexone was developed by Progenics’
former collaboration partner Wyeth. At the time of Wyeth’s acquisition
by Pfizer in October 2009, Progenics regained from Wyeth the rights to
methylnaltrexone, including rights to this methylnaltrexone tablet. The
transfer of data and information to Progenics regarding Wyeth’s work on
oral methylnaltrexone was recently completed and Progenics has now had
the opportunity to review in detail information regarding the
methylnaltrexone tablet which is being reported on today.
The study of the methylnaltrexone tablet was conducted in subjects with
chronic, non-cancer pain receiving various opioid treatment regimens.
Study inclusion criteria required subjects to have a history of OIC.
Subjects were administered a single methylnaltrexone tablet at different
dose levels following an overnight fast. Forty-eight percent of subjects
receiving one of the doses>
Progenics’ analysis and next steps for the methylnaltrexone tablet