apomorphine inhalational (AZ-009) / Ferrer International - LARVOL DELTA

Study to Evaluate the Efficacy and Safety of Staccato Apomorphine (AZ-009) in Patients With Parkinson's Disease Experiencing OFF Episodes (clinicaltrials.gov) - P2 | N=8 | Terminated | Sponsor: Alexza Pharmaceuticals, Inc. | N=50 ➔ 8 | Recruiting ➔ Terminated; Administrative decision

Enrollment change • Trial termination • CNS Disorders • Movement Disorders • Parkinson's Disease

Study to Evaluate the Efficacy and Safety of Staccato Apomorphine (AZ-009) in Patients With Parkinson's Disease Experiencing OFF Episodes (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Alexza Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

Study to Evaluate the Efficacy and Safety of Staccato Apomorphine (AZ-009) in Patients With Established Parkinson's Disease Experiencing OFF Episodes (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Alexza Pharmaceuticals, Inc.

New P2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Safety and pharmacokinetics of multiple dosing with inhalable apomorphine (AZ-009), and its efficacy in a randomized crossover study in Parkinson's disease patients. (PubMed, Parkinsonism Relat Disord) - "AZ-009 is rapidly systemically absorbed and safe to dose three times daily. AZ-009 could provide a faster-acting and easier to use formulation than currently available therapies."

Journal • PK/PD data • CNS Disorders • Cough • Movement Disorders • Parkinson's Disease • Respiratory Diseases

A Randomized Trial Assessing the Safety, Pharmacokinetics, and Efficacy During Morning Off of AZ-009. (PubMed, Mov Disord) - "AZ-009 appears to be a rapid-acting and reasonably well-tolerated formulation for treating off periods."

Clinical • Journal • PK/PD data • CNS Disorders • Movement Disorders • Parkinson's Disease

Treating Morning OFF Episodes in Parkinson’s Disease - Episode 4: Parkinson Disease: SQ Apomorphine Hydrochloride for Morning OFF Episodes (NeurologyLive) - "Peter A. LeWitt, MD: Another option for treating, on demand, the need for getting dopaminergic effect for rescuing a patient from an OFF state is injected apomorphine or apomorphine hydrochloride, which is available in liquid form and an injector that the patient can choose to give up to several times per day. Patients who are started on this therapy are titrated to an effective dose and to get to know it, both from the point of view of its benefits and adverse effects. This medication has been available for many years. It's the first on-demand therapy and can augment the effect of levodopa or other dopaminergic drugs because apomorphine, although it's a synthetic compound as far as the brain is concerned, is a very effective dopaminergic drug. And patients who are injecting this drug get a blood level rapidly, and usually within 10 to 15 minutes can experience a recovery from an OFF state to an ON state."

Video

Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease (clinicaltrials.gov) - P1; N=32; Completed; Sponsor: Alexza Pharmaceuticals, Inc.; Enrolling by invitation ➔ Completed

Clinical • Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease

[VIRTUAL] Randomized, placebo-controlled study investigating the safety, pharmacokinetics and efficacy of inhaled apomorphine in Parkinson’s disease patients (MDS Congress 2020) - "Inhalation of thermally-generated aerosol (Staccato apomorphine) particles could provide a rapid and easy alternative... PD patients tolerated apomorphine inhalation reasonably well. Inhaled apomorphine was rapidly absorbed into the systemic circulation with peak plasma concentrations below 3.5 min. Treatment effects could be shown with MDS-UPDRS III as early as 10 min post-dose at all 3 dose strengths."

Clinical • PK/PD data • CNS Disorders • Pain • Parkinson's Disease