Avanir Pharmaceuticals yesterday announced preliminary results for the quarter ended Sept. 30, 2012.
The company estimates fourth fiscal quarter gross revenue to be $15.4 million, which represents an increase of around 26 percent from the previous quarter. The company’s total operating expenses, not including cost of product sales and non-cash items like share-based compensation, depreciation, and amortization, was between $21.7 and $22.2 million. The company logged more than 11,000 prescriptions for the month of October. Cash, cash equivalents, and investments in securities for Avanir totaled around $72.1 million, which includes cash and cash equivalents of around $69.8 million and restricted investments in securities of around $2.3 million.
Avanir continues making progress on a quarterly basis with its commercial efforts surrounding NUEDEXTA. The company continues to be cost-conscious and anticipates that its total year operating expenses – not counting cost of product sales and non-cash items – will be at the lower end of its $94 million to $96 million guidance.
Avanir has additionally announced that the first-in-human Phase I clinical trial of AVP-786 (formerly known as deuterated dextromethorphan) has been initiated. This trial is designed to assess AVP-786’s single-dose and multiple-dose pharmacokinetics, safety, and tolerability when administered to healthy subjects.
Around 40 people will be enrolled in the randomized crossover study to compare multiple dose levels of AVP-786 – both alone and in combination with quinidine – with dextromethorphan/quinidine. AVP-786’s pharmacokinetic study is anticipated to be completed within the first calendar quarter of 2013.
One goal of the study is to assess whether deuteration of dextromethorphan in AVP-786 confers metabolic properties that are similar to the combination of dextromethorphan with quinidine. Avanir believes that data from this study will be informative for selecting one or more quinidine sparing formulations of AVP-786 to take forward into additional clinical development.
Avanir Pharmaceuticals is a biopharmaceutical company engaged in bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of its commitment, Avanir has extensively invested in its pipeline and is devoted to advancing medicines that can significantly improve the lives of patients and their loved ones.
For more information, visit www.avanir.com
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