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Sunday, Dec 10, 2023

FDA May Delay Avanir’s Laughter Medicine

Crying is no laughing matter to San Diego-based Avanir Pharmaceuticals, Inc., which announced recently that the Food and Drug Administration will likely delay review of Avanir’s drug Neurodex, designed to treat uncontrollable laughter or crying in patients with neurological damage.

Chief Financial Officer Greg Hanson said recent changes the FDA requested to its new drug application are regarding its clerical format, but according to an Avanir press release, the “FDA requested that the company expand certain summary analyses in its application to better support the agency’s new electronic data submission guidelines.”

Hanson said he could not elaborate on what, specifically, the “certain summary analyses” were.

Hanson said the company has a meeting with the FDA in the next few weeks, at which point the company hopes the agency will decide if the drug will be considered with “priority review” status. If the FDA approves the plea, the drug could be approved or denied within six weeks from that point instead of 10 weeks.

Avanir submitted a new drug application to the FDA in December and has been working with the agency to fulfill the requirements, Hanson said.

The company said there is no drug approved for pseudobulbar affect, the uncontrollable laughter or crying condition. Patients who most commonly have the condition include stroke victims, Alzheimer’s, multiple sclerosis or Lou Gehrig’s disease patients.

According to IMS Health, a Fairfield, Conn.-based financial forecasting company that focuses on biotech companies, the market for pseudobulbar affect medications could garner around $450 million this year.

If approved, Neurodex would be Avanir’s second FDA-approved drug. It also markets Abreva, a cold sore medication.

Traded on the American Stock Exchange, Avanir has 60 employees and was founded in 1988. In 2004, it had revenues of $3.6 million, Hanson said, and operated at a $28.2 million loss.

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Twinject In Canada:

Verus Pharmaceuticals, Inc. isn’t wasting any time.

The San Diego company launched Twinject, the first two-dose epinephrine injection, in Canada last month , only a matter of weeks since it launched the device in America.

The injection is used for severe allergic reactions, or anaphylaxis, typically caused by insect stings or food allergies.

While in America, upward of 40 million people are susceptible to the reactions, Verus said Canada has nearly 600,000 people at risk.

Verus will sell the drug in Canada through Montreal-based Paladin Labs, a specialty pharmaceutical company.

The device poses the first major competition for the EpiPen in nearly two decades.

Verus is a pediatric-focused company that develops, acquires and markets drugs for asthma, allergies and related conditions.

Since its inception three years ago, Verus has grown to 75 employees, but had only about three a year ago. It has not yet turned a profit.

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Elderly Insomniacs:

San Diego-based Somaxon Pharmaceuticals Inc. announced recently that it is beginning third phase clinical trials on Silenor, a drug meant for the treatment of insomnia.

The trial will evaluate the safety and efficacy of Silenor over three months in elderly patients with primary chronic insomnia. In early and midstage tests on adults and elderly patients, the drug helped people stay asleep throughout the night and sleep longer, Chief Executive Officer Kevin Cohen has said. Testing on the drug will continue in 2006, he said, with a possible 2007 launch if the FDA approves it.

The company said the drug is nonaddictive. It said all other drugs currently approved by the FDA for insomnia are addictive.

Somaxon is a specialty pharmaceutical company that licenses and develops drugs in the fields of psychiatry and neurology. The company has two other drug candidates in midphase tests, one for smoking cessation and the other for pathological gambling.

Somaxon had the third largest deal with investors in the second quarter, according to a survey released last month conducted by the PricewaterhouseCoopers Health Research Institute.

Contact Katie Weeks with biotechnology news at kweeks@sdbj.com or call her at (858) 277-6359.


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