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): October 29, 2010
Avanir Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-15803
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33-0314804 |
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(State or other jurisdiction of
incorporation)
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(Commission File Number)
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(I.R.S. Employer
Identification No.) |
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101 Enterprise, Suite 300, Aliso Viejo, California
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92656 |
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(Address of principal executive offices)
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(Zip Code) |
Registrants telephone number, including area code: (949) 389-6700
Not Applicable
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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b)) |
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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 October 29, 2010, Avanir Pharmaceuticals, Inc. (the Company) received approval from the Food
and Drug Administration for the commercialization of NUEDEXTA (dextromethorphan
hydrobromide and quinidine sulfate, formerly referred to as AVP-923). NUEDEXTA is indicated for the
treatment of pseudobulbar affect (PBA). PBA occurs secondary to a variety of otherwise unrelated
neurologic conditions and is characterized by involuntary, sudden, and frequent episodes of
laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the
patients underlying emotional state.
Studies to support the effectiveness of NUEDEXTA were performed in
patients with amyotrophic lateral sclerosis (ALS) and multiple
sclerosis (MS). NUEDEXTA has not been shown to be safe and effective
in other types of emotional lability that can commonly occur, for
example, in Alzheimers disease and other dementias.
The Company expects to commercially launch NUEDEXTA in the
first quarter of calendar year 2011. On October 29, 2010, the Company issued a press release
announcing the approval of NUEDEXTA. A copy of this press release is filed herewith as Exhibit
99.1.
On November 1, 2010, the Company announced selected preliminary unaudited financial results for the
fiscal year ended September 30, 2010. The Company estimates that its total cash, cash equivalents
and restricted investments as of September 30, 2010 was approximately $39.4 million, which does not
include, among other things, approximately $3.9 million of proceeds received by the Company subsequent to September 30,
2010 upon the exercise of outstanding common stock warrants.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. |
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Description |
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99.1 |
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Press Release, dated October 29, 2010 |
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