Antipsychotic Long Lasting Drug Approved by FDA

The U.S. Food and Drug Administration has approved a new drug for schizophrenia by Alkermes PLC a biotech company in Ireland with executives based in Waltham.

The new drug, Aristada, is a longer acting version of Abilify an antipsychotic best selling drug that earned over $9 billion last year worldwide, prior to losing its protection from its patent this past April.

Aristada, which is administered through injection, dissolves slowly during a period of four to six weeks and negates the need for a daily pill to be taken.

Aristada, said one doctor is a good option for those who have a hard time taking medications on a regular basis.

Alkermes specializes in making versions that are extended-release of many generically available medications and is not the only company that has an antipsychotic long acting drug on the market.

Otsukas Pharmaceuticals is the Japanese based company that is behind Abilify and since 2013 has sold a once per month form of its antipsychotic known as aripiprazole. The long acting versions of Risperdal, Zyprexa and other drugs for schizophrenia that are commonly prescribed are also available.

Aristada will cost approximately $1,500 per month.

The new medications competitive advantage might come from its length of action and dosing, as doctors are able to choose from one of three drug concentrations, and the highest dose will work up to six weeks.

So that the drug lasts longer, scientists at Alkermes added some fatty tail to each molecule of aripiprazole. Because fat and water do not mix that well, the addition of the fat means that the drug ends up dissolving slower.

As each of the molecules dissolve, an enzyme inside the body clips the fatty tail off, allowing the drug to carry out its job.

This formulation also means Aristada can be sold in a liquid form in syringes that are prefilled, unlike the Abilify made by Otsuka, which comes as powder that must before administration needs to be reconstituted.



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