Attached files
| file | filename |
|---|---|
| EX-99.1 - EXHIBIT 99.1 - OPIANT PHARMACEUTICALS, INC. | opnt003pressrelease_finalx.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): February 12, 2018
OPIANT PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-38193 | 46-4744124 | ||
(State or other jurisdiction of incorporation) | (Commission File Number | (IRS Employer Identification No.) | ||
201 Santa Monica Boulevard, Suite 500 Santa Monica, CA | 90401 | |
(Address of Principal Executive Offices) | (Zip Code) | |
310 598-5410 |
Registrant’s telephone number, including area code |
(Former name or former address if changed since last report,) |
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:
¨ 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))
¨ 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))
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 8.01 Other Events.
On February 12, 2018, Opiant Pharmaceuticals, Inc., a Delaware corporation (the “Company”), announced positive data from a Phase I clinical study of its product candidate OPNT003 (intranasal nalmefene), and provided an update on a meeting held February 8, 2018 with the U.S. Food and Drug Administration (the “FDA”) regarding its planned development program. OPNT003 is in development as a long-lasting opioid antagonist for the treatment of opioid overdose. Based on feedback from the FDA in connection with this meeting, the Company intends to pursue a 505(b)(2) development path, and anticipates the potential to submit a New Drug Application for the drug and intranasal delivery device combination in 2020. Nalmefene for injection was previously approved by the FDA for treating suspected or confirmed opioid overdose.
A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
99.1 |
SIGNATURE
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.
Opiant Pharmaceuticals, Inc. | ||
Date: February 12, 2018 | By: | /s/ David D. O’Toole |
Name: David D. O’Toole | ||
Title: Chief Financial Officer | ||