Can a nasal spray tackle agitation in autism?

The rate at which children are being diagnosed with autism spectrum disorder (ASD) has tripled in the past two decades. According to the Centers for Disease Control and Prevention, while the prevalence was 1 in 150 children in 2000, in the US it rose to a rate of 1 in 44 in 2018.

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

Jeremy Veenstra-Vanderweil, professor of developmental neuropsychiatry at Columbia University Irving Medical Center, explains that movement is seen in a minority of autistic adolescents who struggle with communication. “Most people with agitation have multiple diagnoses such as ASD, intellectual disability (ID), language disorder, or attention deficit hyperactivity disorder (ADHD),” he says.

He further said that the inability to communicate clearly with others and express one’s own wants and needs results in frustration.

off-label drug options

There is no drug specifically approved for agitation associated with ASD and other drugs approved for irritability can be used to manage episodes of agitation, Venestra-Vanderwale says.

Janssen Risperdal (risperidone), a second-generation antipsychotic, received its first FDA approval in 2006 for autism-related irritability for children over the age of five. Marketing Abilify (aripiprazole) was approved by Bristol Myers Squibb and Otsuka Pharmaceuticals. 2009 For the treatment of irritability in children aged six to 17 years with ASD. Generic versions of both drugs are now available.

While effective in decreasing episodes of agitation for most people with autism, risperidone and aripiprazole have side effects such as increased risk of sedation, weight gain and abnormal movements, explains Venestra-Vanderweil.

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

Nasal Spray for Acute Treatment

Impel Pharmaceuticals is addressing this unmet need by developing a nasal spray that administers olanzapine powder. Eli Lilly markets olanzapine under the brand name Zyprexa. Generic olanzapine is an atypical, second-generation antipsychotic agent that blocks dopamine receptors and is approved for bipolar disorder and schizophrenia. Similar to risperidone and aripiprazole, administration of olanzapine is limited to oral tablets and injection, often in a hospital setting.

Impel’s INP-105 is designed to administer 5mg olanzapine powder into the upper nostril space via the company’s Precision Olfactory Delivery (POD) technology. Adams says the device’s trigger mechanism is intended to be a more user-friendly alternative to administering medication in a home setting.

The company recently engaged the first participant 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 special units that look at the continued flow of teens with autism, Adams says. The results of the study are expected in H1 next year.

However, Veenstra-Vanderweil says that a nasal spray still may not be the ultimate solution because it can be just as dangerous for the patient if they don’t understand what’s going on. “Holding one’s head still can be just as uncomfortable and dangerous as holding another part of the body to deliver a shot,” he says.

While this may not be a solution for everyone, having different options will be helpful. There are no nasal sprays available for agitation, nor are there any medications specifically approved for acute agitation in ASD, explains Venestra-Vanderweil. A nasal spray may be a preferred option for some patients, especially if it acts faster than an injection, which is often effective after a period of agitation, he says.

According to a January 2019 press release, in a phase I trial, INP-105 demonstrated its ability to reach plasma levels twice as fast as intramuscular injection of Zyprexa and ten times faster than oral Zyprexa.

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