New treatments for autistic adults are under review after the Food and Drug Administration approved them on Friday, raising concerns about their safety and efficacy.
The drug, dubbed “autistic medication,” is marketed under the brand name “autism medication” and was developed by a company called EpiTherapy.
The FDA approved Epi for children with autism, adults with autism spectrum disorders and children with intellectual disabilities.
The agency said in a statement that it is “reviewing the data and scientific evidence” of the drug’s efficacy.
In a statement, Epi Therapys lawyer, Scott G. Giannini, said the company had no comment.
The Epi drug is approved for use in people with autism and has been marketed under different names over the years.
It is a powerful, long-acting anti-inflammatory medication that can cause temporary paralysis, tremors and other signs of autism, including repetitive behaviors and speech problems.
It’s marketed by the EpiPharmaceuticals unit of Purdue Pharma, the maker of OxyContin.
Giannini said Epi is approved in the United States under a separate prescription-drug program known as the National Institute of Mental Health (NIMH).
The company is not required to disclose the number of Epi prescriptions given in the U.S. The Epi company did not immediately respond to a request for comment.
A spokesperson for Purdue Pharma said the pharmaceuticals subsidiary is reviewing the FDA’s approval.
A spokesman for Epi said the drug has been approved in other countries.
“The company is committed to ensuring that all medicines we develop meet the highest standards of safety, efficacy and quality,” the company said in an emailed statement.
In August, the FDA approved the first-ever generic version of Epis.
The company has been trying to sell its own generic version for some time, and the FDA said it is reviewing that request.
A person familiar with the matter said the generic version would be approved in March or April.
Last month, the Drug Enforcement Administration (DEA) approved Epis as an “autist medication” for adults with autistic children.
The DEA’s director of enforcement, Richard Rosenfeld, said in September that the agency was investigating whether Epis should be used in children and adults with severe developmental disorders.
In April, the agency gave the go-ahead to Epis for use on children with autistic disorders and for people with mild or moderate autism.
The new approval brings the number the drug is available to people with severe or moderate developmental disorders to about 50, the company’s website says.
The decision to approve Epi has drawn attention to concerns about its safety and effectiveness.
The World Health Organization said last year that autism is “probably the most common developmental disorder in the world.”
It added that it could lead to “major complications and, in some cases, death” for the affected individuals.
The U.K.’s Institute for Psychiatry and Psychotherapy said the FDA had the authority to approve a new medication for autistic patients, but said it would do so with “strong oversight and robust oversight.”
The group also said Epis was likely to cause serious harm to the people who receive it, particularly children.
“Epi is being marketed as a treatment for a very serious illness,” said Andrew Wilson, director of the Institute for Psychotherapy and Mental Health.
“If it has serious side effects, it is a major risk to the population.”
The Epis company has said it does not plan to change its name or logo, but it has released a statement saying that it will change its marketing to reflect its product.
“In a world where we are seeing a dramatic increase in autism, we would be remiss not to acknowledge that this medication is a valuable and effective tool for helping people with ASD manage their autism,” Epis spokesperson Gianninis said.
“We have already worked with our partners to ensure that the label and logo are accurately updated, and we will continue to work with our marketing partners to make sure that our products are clear and clear that they are effective.”
In an interview last year with ABC News, Giannis said the Epis brand was “a product of an era” when the autism spectrum disorder was still in its infancy.
“We did not realize how rapidly autism was being misdiagnosed and how quickly it was becoming accepted as normal,” Giannins said.
He said the first batch of Epidiolex, which had been under review, had already gone through more than 2,000 clinical trials and had received over $1 billion in clinical research grants.
The drugs company said it has invested in the development of the first version of the Epidios generic drug, which is called “autic medication.”
The drug will be available for people between the ages of 6 and 14 with a disability that affects their ability to think, talk and communicate.
The second version of “autial medication” is being developed and is expected to be