Alkermes gets US nod for long-acting schizophrenia drug

The US FDA has approved Alkermes’ long-acting injectable (LAI) schizophrenia drug Aristada, the first drug of its type that can be administered at four- or six-weekly intervals.

Alkermes specialises in the development of long-acting medicines and said it had brought “all its experience to bear” in Aristada (aripiprazole lauroxil), which is being pitched as the most flexible and convenient product of its type on the market.

The drug offers “clear efficacy, a range of doses and dosing intervals and the convenience of a ready-to-use product format” that will help it carve out a position in the increasingly crowded market for LAI antipsychotics, said Alkermes’ chief executive Richard Pops on a conference call yesterday.

The new drug has been specifically designed to cater for the varying needs of schizophrenia patients and their healthcare providers. For example it is being launched with three doses that will allow prescribers to match patients to their current dose of oral aripiprazole and also adjust levels up or down as needed.

Approval for administration every six weeks at the highest dose (882mg) is a first among LAIs in the US and should help with patient compliance and convenience, while administration via a pre-filled, non-refrigerated syringe makes it an easier option for delivery in locations such as community mental health centres, according to Alkermes’ chief commercial officer Mark Stejbach.

Aristada launches into an increasingly populated US market and will compete with rival products such as Johnson & Johnson’s Invega Sustenna (paliperidone) and Risperdal Consta (risperidone), Lundbeck’s Abilify Maintena (aripiprazole) and Eli Lilly’s Zypadhera (olanzapine), all of which are administered once a month.

While it has a potential dosing frequency advantage for now, later this year J&J is hoping for approval of a three-monthly formulation of paliperidone which has been tipped by Decision Resources to become a major driver of growth in the schizophrenia market over the next few years.

Pops said that Alkermes is also working on a two-monthly formulation of Aristada.

LAIs currently account for around 14 percent of the total antipsychotic market in the US, but that proportion is expected to increase as doctors become increasingly aware of the benefits of preventing relapse in schizophrenia and more sensitised to the deleterious effects of frequent relapses.

Alkermes is preparing to launch Aristada in the US immediately with a sales force of 175 reps, and will price the new drug “comparable to other products in this class” at a midpoint of around $1,500 a month, according to Stejbach.

He said the profile of the drug means that payers “may actually have an opportunity for savings” versus Aristada’s rivals if they can use the longer dosing interval and lower doses.

Patients outside the US will have a while to wait before Aristada becomes available, however, as Alkermes is anticipating it will have to conduct another trial that is not expected to get underway for some time – possibly until 2017.

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