Replies to post #1276 on Talphera Inc. (TLPH)

[mick]

$ACRX AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. For more information, please select a product below.
DSUVIA® (in US)
PRE-CLINICALPHASE 1PHASE 2PHASE 3NDA FILEDAPPROVED
DZUVEO™ (in EU)
PRE-CLINICALPHASE 1PHASE 2PHASE 3MAA FILEDAPPROVED
Zalviso® (in US)
PRE-CLINICALPHASE 1PHASE 2PHASE 3NDA FILEDAPPROVED
Zalviso® (in EU)
PRE-CLINICALPHASE 1PHASE 2PHASE 3MAA FILEDAPPROVED
ARX-02
PRE-CLINICALPHASE 1PHASE 2PHASE 3NDA FILEDAPPROVED
ARX-03
PRE-CLINICALPHASE 1PHASE 2PHASE 3NDA FILEDAPPROVED


DSUVIA (sufentanil) sublingual tablet 30 mcg

In November of 2018, DSUVIA was approved by the U.S. Food and Drug Administration.

To learn more about DSUVIA, please visit DSUVIA.com.

In June of 2018, AcelRx received approval for DZUVEO from the European Commission for use in medically monitored settings.

Zalviso (sufentanil sublingual tablet system)

Zalviso has completed three Phase 3 clinical trials: two placebo-controlled efficacy and safety trials and one open-label active comparator trial, in which Zalviso was compared to IV PCA morphine. Each of the three Phase 3 trials successfully achieved its primary endpoint. Based on FDA feedback, AcelRx has completed a fourth study (IAP312) in a diverse post-surgical population to further evaluate the overall performance of the Zalviso System.

ARX-02 (higher strength sufentanil sublingual tablets)

A Phase 2 trial evaluating the efficacy and safety of ARX-02 (higher strength sufentanil sublingual tablets) for the treatment of cancer breakthrough pain in opioid-tolerant patients has been completed.

ARX-03 (combination sufentanil/triazolam sublingual tablet)

The combination sufentanil/triazolam sublingual tablet has been studied in a Phase 2 trial, which evaluated the efficacy and safety of this product for procedural anxiety and acute pain.