Alexza’s Adasuve: Poised to launch in Q3, revived antipsychotic will be niche player.
On February 21, 2013, Alexza Pharmaceuticals received marketing authorization from the European Commission for Adasuve (Staccato loxapine) as a treatment for the rapid control of mild to moderate agitation in adult patients with schizophrenia or bipolar disorders. This positive outcome came 2 months after the FDA gave Adasuve the green light for the treatment of acute agitation in schizophrenia and bipolar I disorder, following multiple regulatory setbacks in this market. Alexza plans to launch Adasuve in the US and EU in Q3 2013, with EU partner, Grupo Ferrer, now beginning is pre-launch efforts.
Using Alexza’s proprietary Staccato system, Adasuve delivers an inhaled formulation of loxapine, a typical antipsychotic, to the deep lung. As the first-to-market non-injectable therapy for agitation in schizophrenia and bipolar disorders, Adasuve’s handheld inhaler device is a key product differentiator and provides patients with a fast-acting drug via a non-invasive route of administration. Importantly, Phase III data demonstrate Adasuve’s ability to alleviate agitation 10 minutes after a single dose, which is an improvement upon the 15–30 minutes offered by intramuscular injections.
However, safety concerns have led to restrictions being placed on the clinical settings in which Adasuve can be administered. These concerns, relating to decreased pulmonary function, were highlighted in the first Complete Response Letter issued by the FDA. Consequently, in the US, Adasuve can only be administered in an enrolled healthcare facility which has immediate access to equipment and personnel to manage bronchospasm. Similar stipulations have also been made by the EMA.
Adasuve’s EU labeling is narrower than that in the US in terms of patient potential, restricting its use in the EU to those with “mild to moderate” agitation. Alexza has lost the opportunity to target the severely agitated populations in the EU, which it is able to target in the US. Arguably it is the severely agitated population which has the greatest need for a rapidly acting product such as Adasuve. Furthermore, Adasuve does not address the most pressing clinical unmet needs in these markets. These include therapies for the negative symptoms of schizophrenia and effective therapies for bipolar depression.
Datamonitor anticipates Adasuve will be more frequently prescribed to the schizophrenia population compared to the bipolar disorders population, since the depressive phase in bipolar disorders dominates the long-term course of the condition. Nevertheless, the bipolar disorders market represents the larger population target. Datamonitor estimates that in 2013, there will be 4.4 million prevalent cases of bipolar disorders in the five major EU markets (France, Germany, Italy, Spain, and the UK). In comparison, Datamonitor estimates that there will be almost 2 million prevalent cases of schizophrenia in the five major EU markets in 2013.
Adasuve is a niche product for the schizophrenia and bipolar disorders markets. Datamonitor believes Alexza’s marketing efforts should focus on Adasuve’s key strengths of a rapid onset of action and non-invasive route of administration. This will be important to overcome the barrier to market uptake provided by the restrictions placed on where the product must be administered.