New Long Acting Injection Abilify / Aripiprazole ( Alkermes Aristada) Approved by FDA

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Federal regulators this week approved a new schizophrenia drug from Alkermes PLC, an Irish biotech company with executives based at its Waltham campus.

The drug, Aristada, is a long-acting version of Abilify, a best-selling antipsychotic that earned more than $9 billion worldwide last year, according to IMS Health, before losing patent protection in April.

Administered by injection, Aristada dissolves slowly over four to six weeks, negating the need for daily pill-taking. As many as half of schizophrenia patients on oral antipsychotics don’t end up taking their medications as prescribed.

“Long-acting medications to treat schizophrenia can improve the lives of patients,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Having a variety of treatment options and dosage forms available for patients with mental illness is important so that a treatment plan can be tailored to meet the patient’s needs.”

The efficacy of Aristada was demonstrated in part by a 12-week clinical trial in 622 participants. In participants with acute schizophrenia who had been stabilized with oral aripiprazole, Aristada was found to maintain the treatment effect compared to a placebo.

More information:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465801.htm

More about the company:

Alkermes Web Site:
http://www.alkermes.com/

More information about Antipsychotic Medications:

and

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I take abilify maintena…the injection 300 mg every month. Plus a 15 mg pill nightly. This wasn’t approved previously by FDA? Is there going to be any difference?

I know it’s very expensive but my insurance is some nice guys and give me it for the same price as pills :blush:

I think it’s like $1000 if you don’t have insurance cover it per month!

Will that change?

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Let me look into the difference between Abilify Maintena and this new medication/injectable.

Also… “Aristada will cost about $1,500 a month, comparable to other long-acting antipsychotics.” (still on patent)

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Here is what I’m finding:

Short answer:

They are the same medications (Abilify Maintena and Alkermes Aristada) just in different patented packaging (tiny injectable capsules that release the medications over time).

From a practical standpoint the only difference is this:

Abilify Maintena is available in 1 injection per month

Aklermes Aristada is available in 1 injection per 4 weeks, or 6 weeks (and 8 weeks is coming in 2017 they say).

The Full Story / Long Answer

The company "Otsuka’ in Japan originally developed the drug known as Aripiprazole / Abilify (US name). They partnered with Bristol Myers in the USA to market it.

Then Otsuka partnered with Lundbeck (another US pharma company) to come out with the extended release version of Abilify - called Maintena. This became available in 2013 (drug companies do this - bring out new versions of the drug just when the old drug goes off patent protection - because when it goes off patent protection the amount of money they make does down dramatically.

The original Drug “Aripiprazole” went off patent (so anyone can make it) very recently: Otsuka’s US patent on aripiprazole expired on October 20, 2014; however, due to a pediatric extension, a generic did not become available until April 20, 2015.

So - now anyone can make “Aripiprazole”

Alkermes is basically a “packaging” company. They’ve developed a patented technology for packaging the medication into tiny “microspheres” (tiny balls) that then slowly open up and release the medication in your bloodstream over time.

They have now taken the generic medication and put it inside their patented long release capsules

There have been many lawsuits from Otsuka as they’ve tried to protect the revenue / money that they’ve gotten from Abilify / Aripiprazole and as they’ve tried to stop competitors from developing products like Aristada.

More info here:

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/10/fda-rules-on-the-scope-of-abilify-3-year-exclusivity-and-approves-aristada-with-nce-exclusivity.html

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Cool they have a longer duration in the new drug…I’m on abilify for the long haul so maybe taking the 6 week, and eventually the 8 week drug will be helpful! Thanks!

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I am new to Abilify Maintenance, I’m trying to find insurance to cover the cost and fast. Do you mind me asking what insurance you go through. Any information regarding insurance would to cover the cost would be most appreciated.

Thank you

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I think the person you’re replying to is now called @Jonnybegood . They might be able to answer you when they come online.

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I’ve been on united health care, Medicaid and now Medicare over the years. I think the first two completely covered it and Medicare probably does as well but I’m now on the tablet which costs me $3 a month for abilify.