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NDA of ARX-04 (sufentanil sublingual tablet 30mcg) for Moderate-to-severe acute pain to be filed 2H 2016

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Additional Relevant Details Enrollment in the ongoing SAP302 open-label study in the emergency room will be increased, and a new study known as SAP303 is expected to be initiated in the first quarter of 2016 in postoperative patients with moderate-to-severe pain. SAP303 will focus on enrolling patients greater than 40 years of age and will allow for administration of ARX-04 for up to 12 hours. With these modifications, assuming successful completion of the studies, AcelRx anticipates submitting the NDA for ARX-04 in the second half of 2016
http://news.acelrx.c...
Additional Relevant Details Update on Nov 1 2016: Contingent upon FDA acceptance of the NDA for ARX-04 prior to April 1, 2017,  Hercules has agreed to refinance the loan into a 36-month term note with an additional six month interest only period.
http://news.acelrx.c...
Additional Relevant Details Update on Dec 6 2016:- NDA for ARX-04 on track for submission by year-end
http://news.acelrx.c...
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Occurred on:
Dec 13, 2016
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Related Keywords Nda, Arx-04, Moderate-to-severe Acute Pain, 2h 2016, Sufentanil Sublingual Tablet