Q2 2012 Results (Durect) - Aug 8, 2012 - Anticipated NDA submission for pain in late 2012 or early 2013; Anticipated licensing in territories outside certain Asian and South Pacific markets in 2013 or 2014
Anticipated licensing / partnership • Anticipated NDA • Pain
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Posidur
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"Based on our recent pre-NDA communications with the FDA, we intend to submit a new drug
application for POSIDUR in late 2012 or early 2013," stated James E. Brown, D.V.M., President and CEO of DURECT. "We are also pleased that Pfizer continues to move forward with their efforts to prepare for an FDA interaction later this year with respect to REMOXY and that Zogenixhas commenced a Phase I clinical trial for Relday."
POSIDUR™ (SABER®-Bupivacaine) Post-Operative Pain Relief Depot. Based on recent pre- NDA communications with the FDA regarding POSIDUR, we intend to finish preparing and submit a new drug application (NDA) under 505(b)(2) with the FDA in late 2012 or early 2013.
Business Development Activities.
We have multiple programs that may potentially be licensed over the next 12-18 months. These include POSIDUR,TRANSDUR-Sufentanil, ELADUR, ORADUR-ADHD (territories outside certain Asian and South Pacific markets), as well as various internal programs which we have not described publicly in detail.
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(IR 8)
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