AcelRx Prescribed drugs Broadcasts the European Launch of DZUVEO by its Companion, Aguettant
Pharmaceuticals

AcelRx Prescribed drugs Broadcasts the European Launch of DZUVEO by its Companion, Aguettant

Physicians throughout Europe will now have entry to DZUVEO®, a novel sublingual strategy to acute ache administration in medically supervised settings

HAYWARD, Calif., Oct. 27, 2022 /PRNewswire/ — AcelRx Prescribed drugs, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical firm targeted on the event and commercialization of modern therapies to be used in medically supervised settings, at this time introduced that its business accomplice, Laboratorie Aguettant (“Aguettant”), has launched DZUVEO® (sufentanil sublingual pill, 30 mcg), which is branded as DSUVIA® within the U.S., throughout Europe.

Aguettant entered right into a business collaboration with AcelRx in 2021 and has formally launched throughout key European nations, besides Spain, Portugal and Italy, for which commercialization is predicted to start within the first half of 2023.  Physicians throughout Europe will now have entry to DZUVEO, a sublingual different to straightforward intravenous (IV) opioid analgesics which have undesirable pharmacokinetic and pharmacodynamic efficiency profiles characterised by excessive peak plasma concentrations and the requirement for frequent redosing.  DSUVIA/DZUVEO was designed to supply fast analgesia by way of a non-invasive route and to remove excessive peak plasma ranges, present longer period of motion, and keep away from dosing errors related to IV administration.  As well as, plenty of just lately revealed U.S. research exhibit {that a} sufentanil sublingual pill, 30 mcg administered in numerous medically supervised settings can decrease general perioperative opioid use, in addition to shorten restoration time, in comparison with IV opioids.

“We’re thrilled the Aguettant staff has launched DZUVEO and has now made this novel product out there to healthcare professionals exterior the USA for the primary time,” mentioned Vince Angotti, Chief Government Officer of AcelRx. “We stay impressed with, and are assured within the experience of the Aguettant business staff, and imagine that the latest DSUVIA progress seen over the past 5 quarters right here within the U.S. will help the Aguettant European launch.”

“Partnering with AcelRx and leveraging the information they’ve gained whereas commercializing DSUVIA within the U.S. has been extraordinarily helpful whereas we ready for our launch throughout Europe,” mentioned Eric Rougemond, CEO of Aguettant. “We’re excited to now have DZUVEO as a part of our product portfolio out there to our present clients.  It is a distinctive asset that we imagine may have a profound optimistic impression on the administration of acute ache inside hospitals and different medically supervised settings,” continued Mr. Rougemond.

About DSUVIA (sufentanil sublingual pill), 30 mcg (branded as DZUVEO in Europe)
DSUVIA®, branded as DZUVEO® in Europe, is indicated to be used in adults in licensed medically supervised healthcare settings, equivalent to hospitals, surgical facilities, and emergency departments, for the administration of acute ache extreme sufficient to require an opioid analgesic and for which different therapies are insufficient. DSUVIA/DZUVEO was designed to supply fast analgesia by way of a non-invasive route and to remove dosing errors related to intravenous (IV) administration. DSUVIA/DZUVEO is a single-strength strong dosage kind administered sublingually by way of a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic beforehand solely marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile, when delivered sublingually, avoids the excessive peak plasma ranges and quick period of motion noticed with IV administration. DZUVEO has been authorized by the European Medicines Company and AcelRx’s European commercialization accomplice, Aguettant, will market the drug in Europe.

This launch is meant for traders solely.  For extra data, together with vital security data and black field warning for DSUVIA, please go to www.DSUVIA.com.

There are particular regulatory features of DSUVIA and DZUVEO which can be totally different within the USA and Europe. Please seek advice from the Abstract of Product Traits (SmPC) of DZUVEO within the European nations involved by the advertising and marketing of this specialty product.

About AcelRx Prescribed drugs, Inc.
AcelRx Prescribed drugs, Inc. is a specialty pharmaceutical firm targeted on the event and commercialization of modern therapies to be used in medically supervised settings. AcelRx’s proprietary, non-invasive sublingual formulation know-how delivers sufentanil with constant pharmacokinetic profiles. The Firm has one authorized product within the U.S., DSUVIA® (sufentanil sublingual pill, 30 mcg), generally known as DZUVEO® in Europe, indicated for the administration of acute ache extreme sufficient to require an opioid analgesic for grownup sufferers in licensed medically supervised healthcare settings, and several other product candidates. The product candidates embrace: Zalviso® (sufentanil sublingual pill system, SST system, 15 mcg), an investigational product within the U.S. being developed as an innovatively designed patient-controlled analgesia (PCA) system for discount of moderate-to-severe acute ache in medically supervised settings; two pre-filled, ready-to-use syringes of ephedrine and phenylephrine licensed for the U.S. from Aguettant; Niyad™, a regional anticoagulant for the extracorporeal circuit; and LTX-608, for the potential remedy of COVID-19, disseminated intravascular coagulation, acute respiratory misery syndrome and acute pancreatitis. DZUVEO is an authorized product in Europe.

This launch is meant for traders solely. For added details about AcelRx, please go to www.acelrx.com.

Ahead-looking statements

This press launch comprises forward-looking statements primarily based upon AcelRx’s present expectations. These and some other forward-looking statements are made pursuant to the protected harbor provisions of the Personal Securities Litigation Reform Act of 1995. These statements could also be recognized by means of forward-looking terminology equivalent to “potential,” “imagine,” “anticipate,” “anticipated,” “anticipate,” “could,” “will,” “allow,” “ought to,” “search,” “roughly,” “intends,” “meant,” “plans,” “estimates,” “advantages,” or the destructive of those phrases or different comparable terminology. The dialogue of monetary developments, technique, plans or intentions may additionally embrace forward-looking statements, that are predictions, projections and different statements about future occasions which can be primarily based on present expectations and assumptions. These forward-looking statements contain dangers and uncertainties that would trigger precise outcomes to vary materially from these projected, anticipated or implied by such statements, together with: (i) dangers regarding AcelRx’s product growth actions and ongoing business enterprise operations; (ii) dangers associated to the power of AcelRx and its enterprise companions to implement growth plans, launch plans, forecasts and different enterprise expectations; (iii) dangers associated to sudden variations in market progress and demand for AcelRx’s business and developmental merchandise and applied sciences; (iv) dangers associated to AcelRx’s liquidity and our skill to keep up capital sources; (v) AcelRx’s skill to retaining its itemizing on the Nasdaq change; and (vi) dangers regarding our skill to acquire regulatory approvals for our developmental product candidates. Though it isn’t potential to foretell or determine all such dangers and uncertainties, they could embrace, however usually are not restricted to, these described beneath the caption “Danger Elements” and elsewhere in AcelRx’s annual, quarterly and present studies (i.e., Kind 10-Ok, Kind 10-Q and Kind 8-Ok) as filed or furnished with the Securities and Alternate Fee (SEC) and any subsequent public filings. You’re cautioned to not place undue reliance on any such forward-looking statements, which converse solely as of the date such statements had been first made. To the diploma monetary data is included on this press launch, it’s in abstract kind solely and have to be thought-about within the context of the complete particulars supplied in AcelRx’s most up-to-date annual, quarterly or present report as filed or furnished with the SEC. AcelRx’s SEC studies can be found at www.acelrx.com beneath the “Buyers” tab. Besides to the extent required by legislation, AcelRx undertakes no obligation to publicly launch the results of any revisions to those forward-looking statements to replicate new data, occasions or circumstances after the date hereof, or to replicate the incidence of unanticipated occasions.

SOURCE AcelRx Prescribed drugs, Inc.

AcelRx Prescribed drugs Broadcasts the European Launch of DZUVEO by its Companion, Aguettant