Israeli pharma company Teva has launched Adasuve in the US for the treatment of agitation associated with schizophrenia or bipolar disorder.
Adasuve (loxapine) was originally developed by US company Alexza Pharmaceuticals and becomes the first and only inhaled antipsychotic drug for this indication in the US market. The product was given a green light a year ago in Europe, where it is sold by Spanish pharma company Grupo Ferrer.
According to Teva, the delivery of loxapine using Alexza’s proprietary Staccato inhaler means the active drug enters the blood in around two minutes, providing rapid relief to an agitated patient. Trials show that Adasuve can lead to a statistically significant reduction in agitation at two hours, with an effect seen as early as 10 minutes after dosing.
“Existing treatment options for patients with agitation associated with schizophrenia or bipolar I disorder are limited to oral tablets or injectable modes of administration,” commented Richard Jaffe of the Belmont Center for Comprehensive Treatment in Philadelphia, who was one of the clinical investigators in the Adasuve registration programme.
Adasuve is “a new option to help manage agitation,” he added, noting that this can interfere with the care of patients as it often manifests as threatening, distressing and self-exhausting behaviour that can interfere with their care.
Teva licensed rights to Adasuve last May in a deal that gave Alexza an upfront payment of $40m and up to $195m in payments for regulatory and commercial milestones, as well as tiered royalties on sales. Medivir sub-licensed rights to the product in Nordic countries last September.
Analyst sales forecasts for the new product vary, but have typically been in the $225m to $350m range, depending on the pricing of the product. Initial expectations are that the average wholesale price in the US will range from $75 to $125 per dose.
Alexza is also developing a lower-dose variant of Adasuve in phase II, and has Staccato formulations of alprazolam for acute repetitive seizures (ARS), fentanyl for pain relief and zaleplon for insomnia in early clinical trials.