Trial Profile
A Multi-center, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Staccato Loxapine (ADASUVE®) for Inhalation in Acutely Agitated Patients With Schizophrenia or Bipolar Disorder
Status:
Not yet recruiting
Phase of Trial:
Phase III
Latest Information Update: 06 Jan 2021
Price :
$35
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At a glance
- Drugs Loxapine (Primary)
- Indications Agitation
- Focus Therapeutic Use
- Sponsors Lee's Pharmaceutical
- 31 Oct 2019 Status changed from planning to not yet recruiting.
- 19 Jun 2015 New trial record
- 18 Jun 2015 According to a media release, Alexza Pharmaceuticals plans to transfer the EU Marketing authorization for ADASUVE (MAA) to Ferrer. The MAA transfer includes the responsibilities for the ongoing post-approval clinical studies (the PASS and DUS studies), a planned phase III trial in adolescents and ongoing pharmacovigilance responsibilities.