Drugs / APL-130277
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | — | Parkinson disease | 2019-01-31 | “CRL) from the U.S. Food and Drug Administration ( FDA ) in response to the New Drug Application (NDA) for apomorphine sublingual film (APL-130277)” aquestive.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT02228590 | Aug → Nov 2014 | Parkinson disease | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 32 trials · 1 missed | ||||||
| Phase 3 | NCT03391882 | Dec 2018 → Aug 2021 | Parkinson disease | Sumitomo Pharma America, Inc. | Completed | Missed primary |
| Phase 3 | NCT02542696 | Aug 2015 → Nov 2022 | Parkinson disease | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2020-05-21 | XenoPort, Inc. | Regulatory Aquestive Therapeutics Advances Royalty Monetization Plan as Sunovion Pharmaceuticals’ Apomorphine Sublingual Film Therapy Receives FDA Approval aquestive.com ↗
We are pleased to see that the FDA has granted approval for Sunovion’s apomorphine sublingual film, as expected. |
| 2019-01-31 | XenoPort, Inc. | Regulatory Aquestive Therapeutics Provides Update on Licensee, Sunovion Pharmaceuticals Inc.'s Apomorphine Sublingual Film (APL-130277) New Drug Application aquestive.com ↗
Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products to solve therapeutic problems, learned today its licensee, Sunovion Pharmaceuticals Inc. , received a complete response letter (CRL) from the U.S. Food and Drug Administration ( FDA ) in response to the New Drug Application (NDA) for apomorphine sublingual film (APL-130277). |
All press releases naming this drug 2 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | APL-130277 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03391882 ↗ |