Endo International said today it is withdrawing its supplemental NDA seeking FDA approval for abuse deterrent labeling for its marketed drug Opana® ER—but plans to revisit the issue sometime in the future.
The company said its decision followed a discussion held Thursday with representatives of the FDA. Endo had sought approval on the basis of studies designed to evaluate the abuse deterrence of Opana ER based on its INTAC® Technology formulation, designed to increase tablet hardness using polyethylene oxide, a high-molecular-weight polymer.
Endo said it plans to continue its epidemiological research into abuse deterrence, noting that its withdrawal occurred “without prejudice to refiling” a supplemental NDA at a later date.
“We anticipate the generation of additional data and we will seek collaboration with FDA to appropriately advance Opana ER,” Sue Hall, Ph.D., Endo evp, CSO, and global head of R&D and quality, said in a statement. “We believe in the ability of OPANA® ER to continue making a difference in the lives of appropriate patients and remain committed to safely and effectively addressing the needs of the pain patient community.”
Endo said it had not assumed approval of the supplemental NDA in its financial projections for 2016. On Monday, when it released second-quarter results, Endo reaffirmed its 2016 financial guidance to investors. The company projected total revenue of between $3.87 billion and $4.03 billion, as well as diluted GAPP earnings per share from continuing operations of between $1.86 and $2.16.
Opana ER is Endo’s biggest-selling brand-name pain management treatment and accounted for 13% of Endo’s branded drug net revenues during the second quarter, generating $38.554 million.
However, Opana’s net revenues slid 11% over Q2 2015, due to competition from generic drugs. Opana net revenues also fell by 11% during all of 2015, shrinking to $175.772 million
Endo generates nearly twice as much in net revenues from U.S. generics as from specialty drugs.