0001437749-15-005745.txt : 20150323 0001437749-15-005745.hdr.sgml : 20150323 20150323073213 ACCESSION NUMBER: 0001437749-15-005745 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20150322 ITEM INFORMATION: Other Events FILED AS OF DATE: 20150323 DATE AS OF CHANGE: 20150323 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ACELRX PHARMACEUTICALS INC CENTRAL INDEX KEY: 0001427925 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-35068 FILM NUMBER: 15717677 BUSINESS ADDRESS: STREET 1: 351 GALVESTON DRIVE CITY: REDWOOD CITY STATE: CA ZIP: 94063 BUSINESS PHONE: 650-216-3500 MAIL ADDRESS: STREET 1: 351 GALVESTON DRIVE CITY: REDWOOD CITY STATE: CA ZIP: 94063 8-K 1 acrx20150320_8k.htm FORM 8-K acrx20150320_8k.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): March 22, 2015

 

ACELRX PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

 

 

 

DELAWARE

 

001-35068

 

41-2193603

(State of incorporation)

 

(Commission File No.)

 

(IRS Employer Identification No.)

 

 

351 Galveston Drive

Redwood City, CA 94063

(Address of principal executive offices and zip code)

 

Registrant’s telephone number, including area code: (650) 216-3500

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 
 
 

 

Item 8.01. Other Events.

 

On March 22, 2015, Grünenthal GmbH (Grünenthal) confirmed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had received the submitted responses to the Day 120 List of Questions with respect to the Marketing Authorization Application for ZALVISO™ for the management of moderate-to-severe acute pain in adult patients in a medically-supervised environment and that the review of the response has been initiated. AcelRx and Grünenthal expect to receive the EMA Day 180 List of Outstanding Issues during the second quarter of 2015. The evaluation by the CHMP takes up to 210 active days plus 'clock stops', at the end of which the CHMP will adopt an opinion on whether ZALVISOTM should be marketed or not. This opinion is subsequently transmitted to the European Commission, which has the ultimate authority for granting marketing authorizations in the European Union (EU). AcelRx Pharmaceuticals, Inc. and Grünenthal entered into license and supply agreements for ZALVISO™ in the EU, Australia and certain other countries in December 2013.

 

 
 
 

 

Signatures

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

 

 

Date: March 23, 2015

ACELRX PHARMACEUTICALS, INC.

  

 

 

By:  

/s/ Timothy E. Morris

 

 

 

Timothy E. Morris

Chief Financial Officer