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Can nasal drops tackle autistic agitation?

The rate at which children are identified as having Autism Spectrum Disorders (ASD) has tripled in the last two decades. According to the Center for Disease Control and Prevention, the prevalence was 1 in 150 in 2000, but reached 1 in 44 in 2018 in the United States.

Some people with ASD can experience violent upset and critical behavior. However, because these episodes are managed primarily by relatives and parents at home, it is difficult to estimate the prevalence of acute agitation in ASD, says Adrian Adams, CEO of Impel Pharmaceuticals.

Dr. Jeremy Fernstravanderweele, a professor of developmental neuropsychiatry at Columbia University’s Irving Medical Center, explains that a minority of autistic teens struggling to communicate are excited. .. “Most people who are excited have multiple diagnoses, including ASD, intellectual disability (ID), speech disorders, and attention deficit hyperactivity disorder (ADHD),” he says.

He adds that the inability to communicate clearly with others and express their desires and needs leads to frustration.

Off label medication options

There are no specially approved medications for ASD-related excitement, and other medications approved for hypersensitivity may be used to manage excitement episodes, says Veenstra-Vander Weele.

Janssen’s risperidone (risperidone) is a second-generation antipsychotic drug that received the first FDA approval in 2006 for autism-related hypersensitivity in children ages 5 and older. 2009 for the treatment of hypersensitivity in children aged 6 to 17 years with ASD. Generic versions of both drugs are now available.

Risperidone and aripiprazole are effective in reducing episodes of excitement in most people with autism, but have side effects such as sedation, weight gain, and the risk of abnormal movements, Veenstra-Vander Weele explains.

The route of administration is another hurdle, as both drugs come in the form of oral pills or injections. “It’s difficult to get an excited person to swallow a pill, and shots are unpleasant for most people,” he says.

Nasal drops for acute treatment

Impel Pharmaceuticals addresses this unmet need by developing nasal drops that administer olanzapine powder. Eli Lilly sells olanzapine under the brand name Zyprexa. Generic olanzapine is an atypical second-generation antipsychotic that blocks dopamine receptors and is approved for bipolar disorder and schizophrenia. Like risperidone and aripiprazole, administration of olanzapine is often limited to oral contraceptives and injections in hospitals.

Impel’s INP-105 is designed to administer 5 mg of olanzapine powder to the upper nose via its Precision Olfactory Delivery (POD) technology. The device’s trigger mechanism aims to be a more user-friendly option for administering medicines in the home environment, says Adams.

The company recently administered it to the first participants in a phase IIa placebo-controlled trial investigating INP-105 in 32 adolescents with ASD between the ages of 12 and 17. The study is being conducted in two specialized units that confirm the consistent flow of autistic adolescents. , Adams says. The survey results are scheduled for the first half of next year.

However, Veenstra-VanderWeele states that nasal sprays may not yet be the final solution, as they can threaten patients if they do not understand what is happening. “Holding someone’s head can be as uncomfortable and dangerous as holding another body part to give a shot,” he adds.

It may not be the solution for everyone, but it is useful to have different options. Veenstra-Vander Weele has no nasal drops available for agitation and no drug specifically approved for acute agitation in ASD. Nasal sprays may be the preferred option for some patients, especially if they act faster than injections. Injections are often effective after the agitation period is over.

In a phase I study, INP-105 showed the ability to reach plasma levels twice as fast as intramuscular injection of Zyprexa and ten times faster than oral Zyprexa, according to a January 2019 press release.

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