OT: ALXA: I'm very familiar with it--in fact I picked this program for a Nov 2009 Windhover partnering conference, and I believe it was at that conference that Biovail and Alexza started the partnering process in earnest.
This is what I wrote in a Feb 2009 sidebar entitled 'Wrestling with Agitation:Alexza's Alternative':
"While the cognitive and negative symptoms of schizophrenia are now a major chronic care issue, the positive symptoms often return as the acute-care focus when patients, due to medication noncompliance and/or the fluctuating intensity of their illness, become agitated, with danger to self or others. Alexza's AZ-004/loxapine inhalant delivery system has shown efficacy in Phase III testing, for both schizophrenic and bipolar agitation, and the NDA should be filed in early 2010. It offers an alternative to IM or oral antipsychotic administration (oral medications tend to be too slow, and patients often noncompliant) for agitated patients, which may seem a small issue to outside observers, but is not. During NI's early psychiatric hospital experience/training, this writer participated 800-1000 times in the physical immobilization of psychotic, agitated patients, often so that they could be given IM medications. It was and is a primitive process, three or four staff members tackling the patient; hopefully avoiding being punched, kicked, or bitten; while rolling him/her onto their stomach so that the IM injection can be administered. Even the IM route lags in its effect for 20-40 minutes, during which time the patient often must remain physically restrained, because recipients of a forcible injection in the buttock tend to not perceive this as compassionate medical care. This involves the risk of injury to all who are involved, and the risk of legal action against the hospital and ordering psychiatrist. The age of HIV also introduced the spectre of needle-stick HIV-transmission during this physical tumult. Forcible IM also establishes a climate of coercion and control which is traumatizing, both for the patient being medicated, and for other patients who witness the process. At times, the agitation which required physical restraint then spreads amongst other patients, as if it were contagious. This would be avoided with an inhalant alternative, compliance would undoubtedly be far higher, and its onset of effect much faster. AZ-004 produces a very rapid onset of effect (cMax in two minutes), the trials used 10 minutes as the first timepoint, wherein AZ-004 produced significant relief of agitation. An inhalant antipsychotic is also an intervention that can be offered earlier in the escalation cycle than IM meds, 'nipping it in the bud' before it approaches a dangerous crescendo.
The question is not whether this is a potentially useful tool for dealing with acutely psychotic, agitated patients; it is. The question is whether the American inpatient psychiatry system, which has been gutted by managed care, still exists in large enough scale to provide an adequate market for the product. We were initially skeptical, but the fact is that the highly agitated, psychotic patients who are the key market for AZ-004 are still those most likely to be seen in an ER or inpatient setting. Community mental health centers, which have taken up much of the treatment slack left by the decimation of inpatient alternatives, lack the staffing necessary to provide IM meds, and often have to respond to patient agitation by calling the police, a highly inefficient and clinically counterproductive option.
From a commercial perspective, the shrinkage of the inpatient psychiatric world means that marketing AZ-004 to psych units and emergency rooms would be manageable for a small sales force. In the January issue we suggested that exercising Alexza's increasingly expensive option to regain AZ-004 (and AZ-002) from development partner Symphony Allegro might not be worth the cost. However, in looking more carefully at AZ-004, we believe that conclusion was premature. There will be some pricepoint sensitivity if AZ-004 is $25 per dose, with IM haloperidol at 3.50--though IM Geodon is priced at $35 per dose. But there are also hidden costs to IM med use in terms of staff time, both for the medication administration itself and the incident reports that have to be completed for each involuntary restraint/medication. It is possible that this could become, due to speed and ease of use, a standard of acute care in hospital and mental health center settings, beyond the scope of simply replacing the extreme measure of IM drug administration."
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