REDWOOD CITY, CA, USA I July 25, 2014 I AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company’s new drug application (NDA) for Zalviso™ (sufentanil sublingual tablet system). The Company is currently reviewing the FDA’s comments and requests contained in the CRL and plans to discuss these requests with the FDA.
The CRL contains requests for additional information on the Zalviso System to ensure proper use of the device. The requests include provision of bench data demonstrating a reduction in the incidence of optical system errors which require premature drug cartridge change, changes to the Instructions for Use for the device, and additional data to support the shelf life of the product. We believe some of the requests have been addressed in amendments to the NDA that have been submitted prior to the receipt of the CRL but, as acknowledged by the FDA, have not been reviewed. There is no guarantee that the information previously provided to the FDA will be adequate to address the issues in the CRL. Additional bench testing will be required and human factors testing may be required to address certain items in the CRL. There were no requests to conduct additional human clinical studies.
“We believe we can satisfy all of FDA’s requests in the CRL and resubmit the NDA by the end of 2014, although we will have more clarity on the process and timing after our conversation with FDA,” said Richard King, president and CEO of AcelRx. “We are confident in the Zalviso development program and will work closely with the FDA to address the Agency’s concerns as outlined in the CRL to ensure that healthcare professionals and patient communities will have access to Zalviso.”
Conference Call
There will be a conference call and webcast with AcelRx management on Monday, July 28, 2014 at 8:30 a.m. Eastern time (5:30 a.m. Pacific time) to discuss the Zalviso CRL. The conference call will be available via phone and webcast. The dial in and webcast information is listed below:
Toll-Free US & Canada: 877-407-3109
International: 201-493-6798
Replay Information:
Conference ID #: 13587613
Replay Dial-In (Toll Free US & Canada): 877-660-6853
Replay Dial-In (International): 201-612-7415
Expiration Date: 8/4/14
Webcast URL: http://acelrx.equisolvewebcast.com/q2-2014
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain. AcelRx’s lead product candidate, Zalviso, is designed to improve the management of moderate-to-severe acute pain in adult patients in the hospital setting by utilizing a high therapeutic index opioid, through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. AcelRx has announced positive results from each of the three completed Phase 3 clinical trials for Zalviso, and has submitted an NDA to the FDA seeking approval for Zalviso in the treatment of moderate-to-severe acute pain in adult patients in the hospital setting and on July 25th, received a Complete Response Letter from the FDA. AcelRx plans to initiate a Phase 3 clinical trial for ARX-04, a product candidate for the treatment of moderate-to-severe acute pain in a medically supervised setting, by the end of 2014. The Company has two additional pain treatment product candidates, ARX-02 and ARX-03, which have completed Phase 2 clinical development. For additional information about AcelRx’s clinical programs, please visit www.acelrx.com.
SOURCE: AcelRx Pharmaceuticals
Post Views: 97
REDWOOD CITY, CA, USA I July 25, 2014 I AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company’s new drug application (NDA) for Zalviso™ (sufentanil sublingual tablet system). The Company is currently reviewing the FDA’s comments and requests contained in the CRL and plans to discuss these requests with the FDA.
The CRL contains requests for additional information on the Zalviso System to ensure proper use of the device. The requests include provision of bench data demonstrating a reduction in the incidence of optical system errors which require premature drug cartridge change, changes to the Instructions for Use for the device, and additional data to support the shelf life of the product. We believe some of the requests have been addressed in amendments to the NDA that have been submitted prior to the receipt of the CRL but, as acknowledged by the FDA, have not been reviewed. There is no guarantee that the information previously provided to the FDA will be adequate to address the issues in the CRL. Additional bench testing will be required and human factors testing may be required to address certain items in the CRL. There were no requests to conduct additional human clinical studies.
“We believe we can satisfy all of FDA’s requests in the CRL and resubmit the NDA by the end of 2014, although we will have more clarity on the process and timing after our conversation with FDA,” said Richard King, president and CEO of AcelRx. “We are confident in the Zalviso development program and will work closely with the FDA to address the Agency’s concerns as outlined in the CRL to ensure that healthcare professionals and patient communities will have access to Zalviso.”
Conference Call
There will be a conference call and webcast with AcelRx management on Monday, July 28, 2014 at 8:30 a.m. Eastern time (5:30 a.m. Pacific time) to discuss the Zalviso CRL. The conference call will be available via phone and webcast. The dial in and webcast information is listed below:
Toll-Free US & Canada: 877-407-3109
International: 201-493-6798
Replay Information:
Conference ID #: 13587613
Replay Dial-In (Toll Free US & Canada): 877-660-6853
Replay Dial-In (International): 201-612-7415
Expiration Date: 8/4/14
Webcast URL: http://acelrx.equisolvewebcast.com/q2-2014
About AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain. AcelRx’s lead product candidate, Zalviso, is designed to improve the management of moderate-to-severe acute pain in adult patients in the hospital setting by utilizing a high therapeutic index opioid, through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. AcelRx has announced positive results from each of the three completed Phase 3 clinical trials for Zalviso, and has submitted an NDA to the FDA seeking approval for Zalviso in the treatment of moderate-to-severe acute pain in adult patients in the hospital setting and on July 25th, received a Complete Response Letter from the FDA. AcelRx plans to initiate a Phase 3 clinical trial for ARX-04, a product candidate for the treatment of moderate-to-severe acute pain in a medically supervised setting, by the end of 2014. The Company has two additional pain treatment product candidates, ARX-02 and ARX-03, which have completed Phase 2 clinical development. For additional information about AcelRx’s clinical programs, please visit www.acelrx.com.
SOURCE: AcelRx Pharmaceuticals
Post Views: 97
