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 (Prophylaxis of Gout Flares) | 505(b)(2)
| In-licensed U.S. rights in 2022. Plan to launch in the U.S. in 2024 | ||||
| ELYXYB® (celecoxib) oral solution (Acute Treatment of Migraine ) | 505(b)(2)
| In-licensed U.S. and Canada rights in February 2023. Launched in US in April 2023. Expected 1Q 2024: Acute pain filing | ||||
| SP-102 (Lumbar Radicular/Sciatica Pain) | Fast Track and Pre NDA
| Pivotal Phase 3 trial met primary and secondary endpoints | ||||
| SP-103 Lidocaine Topical System 5.4% (3X)(Chronic Neck Pain) | Fast Track
| 2Q 2023: Completed Phase II Trial. Planning to initiate Phase 2/3 trial for neck pain in 2024. 3Q 2022: Received Fast Track for low back pain | ||||
| SP-104 Delayed Burst Release Low Dose Naltrexone (Fibromyalgia) | Prepare Phase 2 Trial
| Completed multiple Phase 1 trials. | ||||
| Drug | Indication | Stage | ZTlido® (lidocaine topical system) 1.8% | (Post-herpetic Neuralgia-PHN, Shingles pain) | FDA Approved |
|---|---|---|
| GLOPERBA® | (colchicine USP) oral solution (Prophylaxis of Gout Flares) | FDA Approved |
| ELYXYB® | (celecoxib) oral solution (Acute Treatment of Migraine ) | FDA Approved |
| SP-102 | (Lumbar Radicular/Sciatica Pain) | Phase 3 |
| SP-103 | Lidocaine Topical System 5.4% (3X)(Chronic Neck Pain) | Phase 2 |
| SP-104 | Delayed Burst Release Low Dose Naltrexone (Fibromyalgia) | Phase 1 |
ZTLido® Important Safety Information and US Prescribing Information
Gloperba® Important Safety Information and US Prescribing Information
Elyxyb® Important Safety Information and US Prescribing Information
