NeurogesX Inc (fka NGSX)

[surf1944]

7:37AM Neurogesx announced it received a Complete Response Letter from the FDA for its sNDA for Qutenza (NGSX) 0.66 : Co announced that On March 7, 2012, it received a complete response letter from the FDA in response to the its supplemental new drug application (sNDA) filing for Qutenza for the management of pain associated with HIV associated peripheral neuropathy. The complete response letter indicated that in order to gain approval for the use of Qutenza for the proposed indication, the co would need to submit additional clinical data from at least one adequate and well-controlled trial to support the proposed indication. Co plans to work with the FDA to better understand the requirements for potential approval for this important patient population. However, the co does not anticipate investing in further clinical studies for Qutenza at this time.