FDA new approvals, antibiotic and neurological drugs

July 07, 2017

The Avanir drug, Nuedexta, was approved as the first treatment for pseudobulbar affect (PBA) a neurological condition in which patients suffer from uncontrollable outbursts of laughing or crying. Most patients who suffer from PBA are also diagnosed with other neurological disorders like multiple sclerosis or Lou Gehrig's disease. There were concerns that the drug could cause serious heart rhythm disruptions. Avanir reformulated Neudexta at a lower dose and conducted another safety study to assuage FDA concerns. Now the approval has come without a black box warning, but the label does warn doctors to avoid using the drug in certain patients with heart problems and to monitor patients initially to guard against arrhythmias.

Nuedexta is a combination of quinidine, a generic drug that prevents heart arrhythmia, and dextromethorphan, a cough suppressant. The combination is thought to affect the neurotransmitter glutamate, Avanir has revealed. Initially there was 30mg qunidine in the drug which was reduced to 10mg after the rejection by the FDA in 2006 due to arrythmias.

Nuedexta may have sales of $275 million by 2013, said Ritu Baral, an analyst with Canaccord Genuity in New York. Keith Katkin, president and chief executive officer of Avanir, said in the statement that this approval ???marks Avanir??ôs transition toward becoming a commercial enterprise, ready to support the successful launch of the first FDA-approved treatment for pseudobulbar affect.???

They presented the results of their study looking at its efficacy at the American Academy of Neurology??ôs annual meeting in Toronto in April.