CUPERTINO, Calif., May 6 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended March 31, 2009. Total revenues were $6.2 million for the three months ended March 31, 2009, compared to $6.4 million for the same period in 2008. Net loss for the three months ended March 31, 2009 was $8.7 million, compared to a net loss of $7.8 million for the same period in 2008.

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At March 31, 2009, DURECT had cash and investments of $47.0 million, compared to cash and investments of $52.7 million at December 31, 2008; these figures include restricted investments of $0.8 million at March 31, 2009 and $1.0 million at December 31, 2008.

'The most significant events for DURECT during the first quarter were interactions with the U.S. Food & Drug Administration (FDA),' stated James E. Brown, D.V.M., President and CEO of DURECT. 'A successful end-of-Phase II meeting with the FDA was conducted for TRANSDUR(TM)-Sufentanil, and we also recently received FDA feedback on our POSIDUR program, enabling us to construct our Phase III development plans. In addition, we are awaiting a mid-year meeting by King Pharmaceuticals with the FDA to clarify the status of the REMOXY(R) New Drug Application (NDA).'

    Recent Highlights:
    -- Remoxy.  Pain Therapeutics, our licensee, received a Complete Response
       Letter from the FDA in December 2008 indicating that the NDA is not
       approved in its present form. According to Pain Therapeutics, the FDA
       indicated that additional non-clinical data will be required to support
       the approval of REMOXY but the FDA has not requested or recommended
       additional clinical efficacy studies prior to approval. Our
       understanding is that Pain Therapeutics and its commercialization
       collaborator, King Pharmaceuticals, and their outside technical
       advisors have been evaluating the FDA Complete Response Letter and
       there are plans to meet with the FDA in mid-2009, which should provide
       our collaborators with a more reliable context with which to make
       projections about REMOXY.
       REMOXY, an investigational drug, is a long acting oral formulation of
       oxycodone intended to treat moderate to severe pain. Based on DURECT's
       ORADUR(R) technology, which is covered by issued patents and pending
       patent applications owned by us, REMOXY is designed to resist common
       methods of prescription drug misuse and abuse.
    -- POSIDUR(TM) (SABER(TM)-Bupivacaine). We have recently received detailed
       feedback from the FDA on our proposed Phase III program. We are
       pursuing a target label for POSIDUR that would allow POSIDUR to be
       used for a broad range of surgeries. Based on FDA feedback, in
       contrast to the two pivotal efficacy studies that we had previously
       planned, we now anticipate conducting one pivotal efficacy study and
       several other supportive clinical studies in additional surgical
       models to provide greater definition for the settings in which the
       product should be used and to support our target label. We currently
       expect that the total number of patient exposures that we will submit
       to the FDA in an NDA will be approximately 700-800. Under our current
       development program, approximately 300 human subjects have been
       exposed to POSIDUR. Assuming the program progresses as we expect, we
       anticipate that the Phase III program should take approximately two
       years from initiation to NDA filing. To review the major planned
       activities for POSIDUR in 2009:
       -- We expect to have data from our approximately 60 patient Phase IIb
          clinical study in shoulder surgery this year.
       -- We plan to conduct a thorough QTc (tQTc) study in 2009. A tQTc study
          is a cardiac safety test increasingly recommended by the FDA. To
          date, we have not observed any differences in cardiovascular or
          central nervous system side effects between the roughly 300 patients
          dosed to date with POSIDUR versus approximately 150 placebo
          patients.
       -- Nycomed is conducting a Phase IIb study in hysterectomy patients and
          a Phase IIb study in shoulder surgery patients beginning in 2009.
          Those studies will be conducted in a different manner than U.S.
          studies and will be suitable for European regulatory approval
          purposes. We anticipate that these studies will provide data from an
          additional surgical model (hysterectomy) and will add to our safety
          database.
       -- Lastly, we are in discussions with various parties about licensing
          development and commercialization rights to POSIDUR in the U.S.,
          Canada and Asia.
       POSIDUR is our investigational post-operative pain relief depot that
       utilizes our patented SABER technology to deliver bupivacaine to
       provide up to three days of pain relief after surgery.