Drugs / CL-108
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed acute opioid poisoning 1 milestone | |||||
| Filed | US (FDA) | — | acute opioid poisoning | 2016-06-13 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for CL-108” daiichisankyo.com ↗ |
| Rejected Indication not stated 1 milestone | |||||
| Rejected (CRL) | US (FDA) | — | pain, opioid-induced nausea and vomiting | 2017-02-03 | “the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for CL-108” daiichisankyo.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT02712554 | Jun → Sep 2015 | — | Charleston Laboratories, Inc | Completed | Missed primary |
| Phase 1 | NCT02465866 | Nov 2014 → Apr 2015 | — | Charleston Laboratories, Inc | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2017-02-06 | Daiichi Sankyo | Regulatory Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Receive Complete Response Letter from FDA for New Drug Application for CL-108 (hydrocodone, acetaminophen, promethazine) Tablets for Oral Use daiichisankyo.com ↗
The CRL stated that the NDA in its present form was not approved and provided guidance on information needed to resolve matters identified. |
| 2016-06-14 | Daiichi Sankyo | Regulatory Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Announce FDA Acceptance of New Drug Application (NDA) for CL-108 daiichisankyo.com ↗
Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for CL-108 for the relief of moderate to severe pain while preventing or reducing the associated opioid-induced nausea and vomiting (OINV). |
| 2015-10-30 | Daiichi Sankyo | Results Charleston Laboratories, Inc. and Daiichi Sankyo, Inc. Announce Phase 3 Study of CL-108 Met Primary Endpoints daiichisankyo.com ↗
Charleston Laboratories, Inc., and Daiichi Sankyo, Inc., today announced that a third Phase 3 clinical trial of CL-108, an opioid-containing formulation, met its primary endpoints. |
All press releases naming this drug 4 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CL-108 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02465866 ↗ |
| Route | Oral | “single dose by mouth” NCT02465866 ↗ |