By Patrick Crutcher
Avanir Pharmaceuticals (NASDAQ:AVNR) notified shareholders Friday that it had received FDA approval of AVP-923, now known as NUEDEXTA. Friday was a very hectic trading day for investors who saw shares plunge to a low of $1.31 following a bear raid on the stock.
AVNR received FDA approval for NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate), which is indicated for the treatment of pseudobulbar affect (PBA). PBA is a neurologic condition characterized by involuntary, unpredictable and disruptive outbursts of laughing or crying in patients with certain underlying neurologic diseases or injuries. We should note that the FDA approved only the 20/10mg formulation, not the 30/10mg. Additionally, there were no patient population restrictions to MS or ALS patients only. Now that NUEDEXTA is approved, it also has the potential to be used off-label for diabetic peripheral neuropathy pain. This is a future indication AVNR will eventually be pursuing. Off-label use is likely to be negligible given that Medicare or insurance will not likely cover it. Ideally, AVNR will discuss the pricing for NUEDEXTA so that investors can begin modelling future revenue.
One thing to keep in mind is that AVNR has a $75M shelf offering waiting to eventually be exercised; this shelf was made effective on October 28th.
Disclosure: Long AVNR