Collegium Pharmaceutical, Inc, a specialty pharmaceutical company, has received a Notice of Allowance from the US Patent and Trademark Office (US PTO) for its patent application "Modified Release Compositions of Milnacipran", US Patent Application Number 12/211,780. The Notice of Allowance is the US PTO’s official communication that the company’s application has successfully completed examination and that a patent will be issued.

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 US 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.

The recently allowed patent covering a milnacipran formulation follows two previously issued US patents related to Collegium’s development programs with the milnacipran compound. The claims of the previous patents cover active metabolites of the milnacipran (US Patent 7,038,799, "Stereoisomers of p-Hydroxy-Milnacipran") and methods of synthesis (US Patent 7,309,799, "Methods for the Synthesis of Milnacipran and Congeners Thereof"). Collegium also has worldwide patent applications pending that include additional novel formulations of milnacipran. Collegium owns all rights and interests in the three allowed US patents, along with additional foreign patents and pending applications in the US and abroad.

“We are pleased to receive this notice of allowance for this novel formulation of milnacipran," stated Michael Heffernan, president, Collegium Pharmaceutical. “As we are currently focused on the development of DETERx, our tamper resistant, extended release technology, we have commenced discussions with potential development partners with the goal of transitioning this intellectual property into products. To continue the development of these potential products, we are actively seeking a development partner for this programme.”

Collegium Pharmaceutical is a specialty pharmaceutical company focused on the development of proprietary, late stage pharmaceutical products.