The FDA last week approved AcelRx‘s (NSDQ:ACRX) Dsuvia sufentanil product, noting that use of the opioid will be tightly restricted to adults experiencing acute pain in medically-supervised healthcare settings. Dsuvia is a tablet that is administered sublingually in a single-dose, pre-filled applicator. The company expects to launch its pain product in the first quarter of […]
AcelRx shares fall as Sen. Markey calls on FDA to reject opioid painkiller
Shares in AcelRx (NSDQ:ACRX) fell last week after U.S. Sen. Ed Markey (D-Mass) called on the FDA to reject the drugmaker’s opioid painkiller, Dsuvia. The senator noted that the product, which is designed for use in medically-supervised settings, consists of sufentanil – an opioid that is up to 10 times as powerful as fentanyl. “Even in […]
AcelRx tackles acute pain with sublingual drug-delivery tech
While pain medicine specialist Dr. Pamela Palmer was working on the West Coast in the early 2000’s, she noticed something peculiar was happening to patients undergoing surgery – many who survived their procedures were dying of opioid overdoses as a result of patient-controlled drug pumps. “The nurse has to program a number of parameters into […]
AcelRx shares tumble after FDA rejects Dsuvia painkiller
Shares in AcelRx Pharmaceuticals (NSDQ:ACRX) fell more than -50% this morning after the company announced that it received a complete response letter from the FDA for its Dsuvia sufentanil sublingual tablet. The FDA told the company that it can’t approve the new drug application in its present form, saying that AcelRx needs to collect additional data […]
AcelRx’s pain relief drug-device combo succeeds in late-stage trial
AcelRx Pharmaceuticals (NSDQ:ACRX) touted device functionality outcomes today from the Phase III trial of its Zalviso drug-device combination product. Zalviso is designed to deliver a sublingual formulation of an opioid, sufentanil, to adult patients with moderate-to-severe pain in a hospital setting using a hand-held, pre-programmed system. The device allows patients to self-administer sufentanil as often as […]
Anika names medtech veteran as new president | Personnel Moves – July 31, 2017
Anika Therapeutics (NSDQ:ANIK) last week named medtech veteran Joseph Darling as president, taking over the role from CEO Charles Sherwood. The chief exec plans to stay in the corner office as he transitions the role of president to Darling. Previously, Darling worked as an executive in privately-held orthopedic companies. He has also held senior level executive […]
AcelRx touts data from Dsuvia pain relief trials
AcelRx Pharmaceuticals (NSDQ:ACRX) touted efficacy and safety data today for its pain reliever, Dsuvia. The company’s lead drug candidate is composed of 30 sufentanil tablets delivered sublingually using a disposable, pre-filled single-dose applicator. Dsuvia is investigational and not approved in any country. The 4 late-phase studies enrolled 480 patients total. In 2 randomized studies, enrolled patients underwent bunionectomy […]
AcelRx gains on Q4 earnings
Shares in AcelRx Pharmaceuticals (NSDQ:ACRX) rose today after the pharmaceutical company met expectations on Wall Street with its 4th quarter results. The Redwood City, Calif.-based company pared its losses to -$9.7 million, or -21¢ per share, on sales of $6.4 million for the 3 months ended Dec. 31, for bottom-line growth of 8.2% on sales growth of […]
FDA accepts AcelRx’s NDA for Dsuvia pain reliever
AcelRx Pharmaceuticals (NSDQ:ACRX) said today that the FDA accepted the company’s New Drug Application for its Dsuvia pain relief therapy. The federal watchdog set a target decision date for October 12 this year. The company’s Dsuvia candidate is composed of 30 sufentanil tablets delivered sublingually using a disposable, pre-filled single-dose applicator to patients with moderate-to-severe […]
AcelRx touts Dsuvia data for burn victims
AcelRx Pharmaceuticals (NSDQ:ACRX) said today that it plans to present data from a study evaluating its Dsuvia pain reliever in patients with moderate-to-severe acute pain resulting from trauma or injury. The company’s Dsuvia candidate is composed of 30 sufentanil tablets delivered sublingually using a disposable, pre-filled single-dose applicator. Dsuvia is investigational and not approved in […]
