Staccato® Platform Performance

Clinical trial data indicate that Alexza’s unique Staccato technology generates consistent distribution of aerosolized drug particles of 1 to 5 microns (the ideal size for absorption in deep lung tissue), providing peak plasma concentrations as quickly as an intravenous injection and rapid onset of therapeutic relief.

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The Staccato® System

Alexza's Technology Foundation

The heart of the hand-held Staccato® system is a heat package with a stainless steel substrate, onto which a thin film of unformulated drug is coated. When the patient draws a normal breath through the Staccato system, the substrate surface instantaneously heats to create a condensation aerosol. The patient inhales perfectly sized particles of pure drug down into the narrower, more vascularized tissue of the deep lung, allowing fast and more complete absorption into the bloodstream.

The Staccato System

We believe our Staccato system matches delivery characteristics and product attributes to patient needs for acute and intermittent conditions, with the following advantages:

Rapid Onset

The aerosol produced with the Staccato system is designed to be rapidly absorbed through the deep lung with a speed of therapeutic onset comparable to an IV injection, generally achieving peak plasma levels of drug in two to five minutes.

Ease of Use

The Staccato system is breath actuated, and a patient simply inhales to administer the drug dose. Unlike injections, the Staccato system is noninvasive and may not require caregiver assistance. The aerosol produced with the Staccato system is relatively insensitive to patient inhalation rates. Unlike many other inhalation technologies, the patient does not need to learn a special breathing pattern. In addition, the Staccato device is small and easily portable.

Consistent Particle Size and Dose

The Staccato system uses rapid heating of the drug film to create consistent and appropriate particle sizes for deep lung inhalation and absorption into the bloodstream. The Staccato system also produces a consistent high emitted dose, regardless of the patient’s breathing pattern.

Broad Applicability

We have screened over 400 drugs, and approximately 200 have exhibited initial vaporization feasibility using our Staccato system. The Staccato system can deliver both water-soluble and water-insoluble drugs and eliminates the need for excipients and additives such as detergents, stabilizers and solvents, avoiding the side effects that may be associated with the excipients or additives.

Design Flexibility

The Staccato system can incorporate multiple features, including lockout to potentially enhance safety, the convenience of patient titration and a variety of dose administration regimens.

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