AcelRx Pharmaceuticals (NSDQ:ACRX) said today that it submitted a new drug application to the FDA for its ARX-04 sublingual sufentanil tablet. The non-invasive compound has been studied as a treatment for patients experiencing moderate or severe acute pain and is administered in a medically supervised setting using a disposable, pre-filled, single-dose applicator. The Redwood City, Calif.-based […]
AcelRx
FDA rejects AcelRx's request for meeting on pain drug device
FDA seeks additional trial on Zalviso drug-device combo from AcelRx
(Reuters) — AcelRx Pharmaceuticals (NSDQ:ACRX) said the FDA wants an additional study on its Zalviso drug-device combination, which the safety watchdog already rejected once last year.