Our Development Programs
Program (click indication for details)
NDA / MAA
ADASUVE®: Staccato loxapine
- To see full prescribing information, including boxed warning, visit www.ADASUVE.com
AZ-104: Staccato loxapine
- INTENDED INDICATION: Migraine Headache
- PATIENT POPULATION: 13 million people in the United States receive medication for migraine, 29.5 million people in the United States have migraine headaches*.
- STATUS:168-patient Phase 2a proof-of-concept trial and 360-patient Phase 2b trial completed.
* Loxapine is a non-triptan with potential to serve the 50% of migraine sufferers who either get little relief from or are ineligible to receive triptans because of the potential cardiovascular side-effects of triptans.
- INTENDED INDICATION: Breakthrough Pain
- PATIENT POPULATION: Based on our analysis of industry data and clinical literature, we believe over 25 million postoperative patients experience inadequate pain relief, despite receiving some form of pain management and, according to a three month study on cancer pain by Portenoy and Hagen and a cross-sectional study on cancer pain by Caraceni, approximately 65% of patients diagnosed with cancer pain experience breakthrough cancer pain.
- STATUS: A 50-subject Phase I safety, pharmacokinetics and pharmacodynamics (using multi-dose Staccato system) completed. with positive results reported.
AZ-002 Staccato alprazolam
- INTENDED INDICATION: Acute Repetitive Seizures
- STATUS: 50-subject Phase 1 trial and an abuse liability trial have been completed.
- INTENDED INDICATION: Insomnia in patients who have difficulty falling asleep, including patients who awake in the middle of the night and have difficulty falling back to sleep
- PATIENT POPULATION: An estimated 10-30% of people in the United States experience either chronic or occasional insomnia.
- STATUS: 40-subject Phase 1 safety and pharmacokinetics trial completed with positive results reported.
Staccato nicotine (Preclinical)
- INTENDED USE: Staccato nicotine is being designed to help smokers quit by addressing both the chemical and behavioral components of nicotine addiction by delivering nicotine replacement via inhalation.
- STATUS: Cypress Bioscience acquired the worldwide license for the Staccato Nicotine technology in August 2010.
Moving Forward with a Portfolio of Clinical Programs
Virtually everyone has experienced unpleasant medical symptoms. For those with serious diseases like cancer, severe pain uncontrolled by conventional medications can be a devastating reality of daily life. Even for those in good health, a sleepless night for example, can disrupt work or family responsibilities. Our focus is empowering individuals to treat their own symptoms immediately at the time they occur.
Acute and intermittent medical conditions are characterized by a rapid onset of symptoms that are temporary and severe, and that occur at irregular intervals, unlike the symptoms of chronic medical conditions that continue at a relatively constant level over time. Approved drugs for the treatment of many acute and intermittent conditions, such as antipsychotics to treat agitation, non-benzodiazepines to treat insomnia and benzodiazepines to treat seizures, are typically delivered either in tablets, by injection or other inconvenient routes of administration. Traditional inhalation technologies are also being developed to treat these conditions. These delivery methods have the following advantages and disadvantages:
Oral tablets or capsules are convenient and cost effective, but they generally do not provide rapid onset action. Oral tablets may require at least one to four hours to achieve peak plasma levels. Also, some drugs, if administered as a tablet or capsule, do not achieve adequate or consistent bioavailability due to the degradation of the drug by the stomach or liver or inability to be absorbed into the bloodstream.
IV injections provide a rapid onset of action and can sometimes be used to titrate potent drugs with very rapid changes in effect. Titration refers to the ability to administer an initial dose of medication and then determine if the medication is effective; if the medication is effective no further dosing is required. However, if the medication is not yet effective, another dose can be administered, and this process can be repeated until it is determined that the medication had had an adequate effect. However, IV injections generally are administered by trained medical personnel in a medical care setting. Other forms of injections result in an onset of action that is generally substantially slower than IV injection, although often faster than oral administration. All forms of injections are invasive, can be painful for some patients and are often expensive. In addition, many drugs are not water soluble and can be difficult to formulate in an injectable form.
Traditional dry powder and aerosolized inhalation delivery systems have been designed and used primarily for local delivery of the drugs to the respiratory airways, not to the deep lung for rapid systemic drug delivery. Certain recent variants of these systems, however, can provide systemic delivery of drugs, either for the purpose of rapid onset of action or to enable noninvasive delivery of drugs that are not orally bioavailable. Nevertheless, many of these systems have difficulty generating appropriate drug particle sizes and consistent emitted doses for deep lung delivery. To achieve appropriate drug particle sizes and consistent emitted doses, most traditional inhalation systems require the use of excipients and additives such as detergents, stabilizers and solvents, which may potentially cause toxicity or allergic reactions. Many traditional inhalation devices require patient coordination to deliver the correct drug dose, leading to potentially wide variations in the amount of drug delivered to a patient.
As a result of these limitations, we believe there is a significant unmet medical and patient need for products for the treatment of acute and intermittent conditions that can be delivered in precise amounts, provide rapid therapeutic onset, and are noninvasive and easy to use.
We have already demonstrated that more than 200 FDA-approved compounds are feasible for delivery by the Staccato® system. Currently we have six development programs focused on different acute and intermittent conditions.