Monday, June 28, 2021 1:09:51 PM
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.
Recent TLPH News
- Talphera to Participate in the H.C. Wainwright 26th Annual Global Investment Conference • PR Newswire (US) • 09/05/2024 08:15:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/03/2024 08:22:55 PM
- Talphera Announces First Patient Enrolled in the Registrational Trial Evaluating Nafamostat for Anticoagulation of the Extracorporeal Circuit • PR Newswire (US) • 08/19/2024 12:30:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 08/14/2024 09:22:34 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2024 08:12:36 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2024 08:10:32 PM
- Talphera Announces Second Quarter 2024 Financial Results and Provides Corporate Update • PR Newswire (US) • 08/14/2024 08:01:00 PM
- Talphera to Host Second Quarter 2024 Financial Results and Corporate Update Call and Webcast on Wednesday, August 14, 2024 • PR Newswire (US) • 08/05/2024 08:05:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/14/2024 09:19:26 PM
- Talphera Announces Inducement Grants under Nasdaq Listing Rule 5635(c)(4) • PR Newswire (US) • 05/20/2024 09:25:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 05/20/2024 09:22:15 PM
- Talphera to Participate at A.G.P. Virtual Healthcare Conference • PR Newswire (US) • 05/16/2024 09:45:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/14/2024 09:00:59 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/14/2024 08:15:28 PM
- Talphera Announces First Quarter 2024 Financial Results and Provides Corporate Update • PR Newswire (US) • 05/14/2024 08:05:00 PM
- Talphera to Host First Quarter 2024 Financial Results Call and Webcast on Tuesday, May 14, 2024 • PR Newswire (US) • 05/02/2024 08:15:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 03/06/2024 10:00:48 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 09:11:29 PM
- Talphera Announces Fourth Quarter 2023 Financial Results and Provides Corporate Update • PR Newswire (US) • 03/06/2024 09:05:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/05/2024 01:55:33 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/05/2024 01:54:23 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/05/2024 01:53:08 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/01/2024 12:35:13 PM
- Talphera Announces Reduction in Size of its Board of Directors from Ten to Seven Members • PR Newswire (US) • 03/01/2024 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/28/2024 02:06:44 AM
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