AcelRx’s DZUVEO receives EU approval for management of acute moderate to severe pain in medically monitored settings
REDWOOD CITY, CA, USA I June 27, 2018 I AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the Company), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, today announced that the European Commission (EC) has approved DZUVEO (under development in the U.S. as DSUVIA™) for the management of acute moderate to severe pain in adults in medically monitored settings.
“The EC approval is an important milestone for AcelRx, and an exciting new opportunity for healthcare providers for managing acute moderate to severe pain in medically monitored settings. The current standard of care in these settings is primarily intravenous opioids,” said Vince Angotti, Chief Executive Officer of AcelRx. “DZUVEO is a novel, non-invasive, sublingual tablet that we expect will challenge the current standard of care and provide a new option to healthcare practitioners that does not require the time, expense and effort to start an intravenous line.”
DZUVEO represents the second EC approval for an AcelRx developed product, with the first being ZALVISO, which is currently being marketed in Europe by Grünenthal.
AcelRx previously announced the acceptance of the resubmitted New Drug Application for DSUVIA (approved in Europe as DZUVEO) by the U.S. Food and Drug Administration, for which the FDA has assigned a PDUFA (Prescription Drug User Fee Act) date of November 3, 2018.
About DZUVEO (tradename of DSUVIA in the U.S.)
DZUVEO (sufentanil sublingual tablet, 30 microgram), under development as DSUVIA in the U.S., is designed to reduce acute moderate-to-severe pain in medically monitored settings and address dosing errors associated with intravenous (IV) administration via its non-invasive single-dose applicator (SDA). Sufentanil is an opioid analgesic currently marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration while still providing rapid pain relief. The safety and clinical utility of DZUVEO has been established in patients following multiple types of surgery, as well as in patients presenting to the emergency room with moderate to severe pain due to trauma, injury or illness. In the U.S., the U.S. Food and Drug Administration assigned the Company a Prescription Drug User Fee Act (PDUFA) date of November 3, 2018 for a decision on its resubmitted DSUVIA NDA (New Drug Application).
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx’s proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has two product candidates in the United States, including DSUVIA™ (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ outside the United States, with a proposed indication for the treatment of moderate to severe acute pain in medically supervised (or monitored) settings, and Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg) being developed as a non-invasive patient-controlled analgesia (PCA) system for treatment of moderate to severe acute pain in medically supervised settings. The Company has received EC approval for Zalviso and DZUVEO for marketing in the Europe.
SOURCE: AcelRx Pharmaceuticals
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AcelRx’s DZUVEO receives EU approval for management of acute moderate to severe pain in medically monitored settings
REDWOOD CITY, CA, USA I June 27, 2018 I AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the Company), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, today announced that the European Commission (EC) has approved DZUVEO (under development in the U.S. as DSUVIA™) for the management of acute moderate to severe pain in adults in medically monitored settings.
“The EC approval is an important milestone for AcelRx, and an exciting new opportunity for healthcare providers for managing acute moderate to severe pain in medically monitored settings. The current standard of care in these settings is primarily intravenous opioids,” said Vince Angotti, Chief Executive Officer of AcelRx. “DZUVEO is a novel, non-invasive, sublingual tablet that we expect will challenge the current standard of care and provide a new option to healthcare practitioners that does not require the time, expense and effort to start an intravenous line.”
DZUVEO represents the second EC approval for an AcelRx developed product, with the first being ZALVISO, which is currently being marketed in Europe by Grünenthal.
AcelRx previously announced the acceptance of the resubmitted New Drug Application for DSUVIA (approved in Europe as DZUVEO) by the U.S. Food and Drug Administration, for which the FDA has assigned a PDUFA (Prescription Drug User Fee Act) date of November 3, 2018.
About DZUVEO (tradename of DSUVIA in the U.S.)
DZUVEO (sufentanil sublingual tablet, 30 microgram), under development as DSUVIA in the U.S., is designed to reduce acute moderate-to-severe pain in medically monitored settings and address dosing errors associated with intravenous (IV) administration via its non-invasive single-dose applicator (SDA). Sufentanil is an opioid analgesic currently marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration while still providing rapid pain relief. The safety and clinical utility of DZUVEO has been established in patients following multiple types of surgery, as well as in patients presenting to the emergency room with moderate to severe pain due to trauma, injury or illness. In the U.S., the U.S. Food and Drug Administration assigned the Company a Prescription Drug User Fee Act (PDUFA) date of November 3, 2018 for a decision on its resubmitted DSUVIA NDA (New Drug Application).
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. AcelRx’s proprietary, non-invasive sublingual formulation technology delivers sufentanil with consistent pharmacokinetic profiles. The Company has two product candidates in the United States, including DSUVIA™ (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ outside the United States, with a proposed indication for the treatment of moderate to severe acute pain in medically supervised (or monitored) settings, and Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg) being developed as a non-invasive patient-controlled analgesia (PCA) system for treatment of moderate to severe acute pain in medically supervised settings. The Company has received EC approval for Zalviso and DZUVEO for marketing in the Europe.
SOURCE: AcelRx Pharmaceuticals
Post Views: 32
