Collegium Pharmaceutical, Inc., a specialty pharmaceutical company,
today announced that it has received a Notice of Allowance from the U.S.
Patent and Trademark Office (USPTO) for its patent application "Modified
Release Compositions of Milnacipran", US Patent Application Number
12/211,780. The Notice of Allowance is the USPTO's official
communication that the Company's application has successfully completed
examination and that a patent will be issued.
“Methods for the Synthesis of
Milnacipran and Congeners Thereof”
Once issued, the patent will provide broad coverage for Collegium's
novel once-a-day formulation of the active pharmaceutical ingredient,
milnacipran HCl. Milnacipran HCl, a selective serotonin and
norepinephrine dual reuptake inhibitor, was recently approved by the
U.S. Food and Drug Administration (FDA) for the management of
fibromyalgia. It is currently marketed in an immediate release
formulation, requiring twice daily dosing, by Forest Laboratories, Inc.
under the trade name Savella®. Fibromyalgia is a chronic condition
characterized by widespread pain and decreased physical function. It is
estimated that as many as six million people in the United States suffer
from the condition.