Item 8.01 Other Events
Opiant Pharmaceuticals, Inc ("Opiant") has previously announced that it has
initiated human use characteristic studies with the drug delivery device that
will be used in both the confirmatory pharmacokinetic ("PK") study of nasal
nalmefene, OPNT003 for the treatment of opioid overdose, and the potential
commercialization of the product following regulatory approval from the United
States Food and Drug Administration (the "FDA"). Opiant has also previously
announced that it was planning for a confirmatory PK study of OPNT003 and
expected to report top-line data in the first quarter of 2020 and file a New
Drug Application for OPNT003 in 2020.
On January 16, 2020, Opiant's management team participated in a call with the
FDA in connection with the PK study for OPNT003. The FDA communicated to Opiant
on the call that they were in the process of reviewing certain characteristics
of the drug delivery device and that the confirmatory PK study of OPNT003, which
Opiant planned to initiate and complete in the first quarter of 2020 using the
drug delivery device, be put on hold pending a formal comment letter to be sent
by the FDA. At this time, Opiant is not aware of the details of the FDA's review
and is therefore unable to verify whether it will be able to initiate the
confirmatory PK study of OPNT003 in the first quarter of 2020. Given this new
development, Opiant will not be able to complete the study in the first quarter
of 2020.
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OPIANT PHARMACEUTICALS, INC. 
