Incline, a hospital-focused specialty pharmaceutical company, produces a needleless patient-controlled IONSYS (fentanyl iontophoretic transdermal system) used for the short-term management of acute postoperative pain in adult patients requiring opioid analgesia during hospitalization.

The Medicines Company said IONSYS formed the basis of FDA and European Medicines Agency (EMA) marketing clearances in 2006, as it was demonstrated in seven Phase 3 clinical trials.

IONSYS, which was acquired from ALZA, was launched in Europe in 2008 and achieved strong hospital formulary acceptance.

The device, however, due to device stability issues was voluntarily recalled in Europe and was not launched in the US.

The Medicines Company president and chief financial officer Glenn Sblendorio said to address prior challenges, Incline has prepared the product for near-term resubmission to make the product available in the US and Europe.

"We expect that if we obtain IONSYS approval, we could launch IONSYS in early 2014 in the US and soon thereafter in Europe," Sblendorio added.

Incline Therapeutics chief executive officer Alan Levy said, "We have great confidence in their ability to optimize the therapeutic and commercial potential of IONSYS."

The Medicines Company said it will also provide Incline with additional payments, if certain regulatory and commercial milestones are met.