Drug for uncontrollable laughing and crying is moving toward European licensing

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In December last year, we told you about a new drug for uncontrollable laughter and crying (known as the pseudobulbar affect) called Nuedexta that had been approved for use by the Food and Drugs Agency in the USA, and that plans were in place to start the process to gain a European license for the drug in 2011. A number of people affected by this particular symptom of MND have asked us for an update on the progress of Nuedexta, which may also be helpful to others.

From their discussions, the pharmaceutical company Avanir Pharmaceuticals decided to request an accelerated review process and the European Medicines Agency (EMA) agreed that this process could be centralised. This basically means that the EMA could decide to shorten some of the regulatory timelines. In addition, if approved, it can be licensed to all European Union member states at the same time through this one application process. This is important as it means that the pharmaceutical company won’t have to apply to all European countries separately which could have slowed down the process of making it available more broadly.

Once the review is complete, EMA will adopt an opinion on whether Nuedexta should be marketed or not. This opinion is then sent to the European Commission – which has the ultimate authority for granting marketing authorisation across Europe.

Randall Kaye, MD Chief Medical Officer at Avanir Pharmaceutical says: “As soon as the European Commission has approved the decision of EMA, it should be made available in the UK, which means it could be available in first half of 2013.

“Avanir will continue to work with EMA to help make Nuedexta available to patients with pseudobulbar affect as quickly and safely as possible.”

The speed of regulatory assessment in Europe is improving. The regulatory authorities have really ‘upped their game’ over the past few years, with recognising that drugs for disease such as MND need to be pushed through quickly, while still maintaining their high standards of quality control.

We hope you find this information useful as an update. We’ll keep an eye out over the next few months on developments with Avanir Pharmaceuticals and will update our blog with any news of its licensing.

Avanir Pharmaceuticals published a press release on this news story in July

3 thoughts on “Drug for uncontrollable laughing and crying is moving toward European licensing

  1. Very useful update. It’s good that there’s a central European acceptance process rather than individual countries. Good work and keep going to speed up the acceptance of drugs that can help some of us that are already being used in the USA.

  2. Subsequent to the July press release, Keith Katkin, CEO of Avanir, announced at investor conferences that the EMA will not require Avanir to submit a pediatric investigation plan (PIP). Avanir expects to file by the end of calendar year 2011, and with an accelerated review the EMA could render a decision by June of 2012.

  3. ALISO VIEJO, Calif., April 26, 2013 /PRNewswire/ — Avanir Pharmaceuticals, Inc. (AVNR) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for NUEDEXTA® (dextromethorphan hydrobromide and quinidine sulfate), recommending NUEDEXTA be approved for the treatment of pseudobulbar affect (PBA), irrespective of neurologic cause. In addition, the CHMP also recommended approval of two dose strengths of NUEDEXTA; 20/10 mg and 30/10 mg capsules

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