Pipeline
| Phase 1 | Phase 2 | Phase 3 | NDA/MAA Filing | Approved | Milestones | |
|---|---|---|---|---|---|---|
| ZTlido® (lidocaine topical system) 1.8% (Post-herpetic Neuralgia-PHN, Shingles pain) | 505(b)(2)
|
Launched in the U.S. in October 2018 | ||||
| GLOPERBA® (colchicine USP) oral solution (Treatment of Gout) | 505(b)(2)
|
In-licensed U.S. rights in 2022. Plan to launch in the U.S. in 2023 | ||||
| ELYXYB™ (celecoxib) oral solution (Acute Treatment of Migraine ) | 505(b)(2)
|
In-licensed U.S. and Canada rights in February 2023. Plan to launch in the U.S. in 1H2023 | ||||
| SP-102 (Lumbar Radicular/Sciatica Pain) | Fast Track and Pre NDA
|
Results from pivotal Phase 3 trial achieved primary and secondary endpoints | ||||
| SP-103 Lidocaine Topical System 5.4% (3X)(Acute Low Back Pain) | Fast Track
|
Initiated Phase 2 trial in the second quarter of 2022 | ||||
| SP-104 Delayed Burst Release Low Dose Naltrexone (Fibromyalgia) | Prepare Phase 2 Trial
|
Completed multiple Phase 1 trials. Plan to initiate Phase 3 in 2023. | ||||
| Drug | Indication | Stage | ZTlido® (lidocaine topical system) 1.8% | (Post-herpetic Neuralgia-PHN, Shingles pain) | FDA Approved |
|---|---|---|
| GLOPERBA® | (colchicine USP) oral solution (Treatment of Gout) | FDA Approved |
| ELYXYB™ | (celecoxib) oral solution (Acute Treatment of Migraine ) | Milestones |
| SP-102 | (Lumbar Radicular/Sciatica Pain) | Phase 3 |
| SP-103 | Lidocaine Topical System 5.4% (3X)(Acute Low Back Pain) | Phase 1 |
| SP-104 | Delayed Burst Release Low Dose Naltrexone (Fibromyalgia) | Phase 2 |
ZTLido® Important Safety Information and US Prescribing Information
Gloperba® Important Safety Information and US Prescribing Information
Elyxyb™ Important Safety Information and US Prescribing Information