Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ADS-5102 (extended release amantadine HCl)
ADS-5102 · 7 trials · 8 indications
The incidence of treatment-emergent adverse events was used as the measure for long-term safety and tolerability of ADS-5102.
The T25FW is a measure of lower extremity function. The subject is directed to a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the subject walk back the same distance. For this outcome measure, the result is reported as speed (feet per second). Improvement is indicated by an increase in speed.
The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 4, 8, and 12.
The primary objective of the study was to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release (ER) formulation of amantadine, administered at a dose of 340 mg once daily at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD).
The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 8, 12, 18, and 24.
The UDysRS is a dyskinesia rating scale from 0-104, and it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The last observation carried forward (LOCF) method was used for analysis. Participants were summarized according to the actual treatment received.
| Arm | Type | Description |
|---|---|---|
| ADS-5102, 274 mg | EXPERIMENTAL | 274 mg ADS-5102, administered once daily at bedtime for up to 52 weeks |
| ADS-5102, 137 mg | EXPERIMENTAL | ADS-5102, administered once daily at bedtime from Week 4 through Week 16 |
| Placebo | OTHER | placebo, administered once daily at bedtime from Week 4 through Week 16 |
| ADS-5102 (amantadine HCl extended release) | EXPERIMENTAL | ADS-5102 (amantadine HCl extended release) |
| ADS-5102 | EXPERIMENTAL | amantadine HCl extended release |
| Treatment A | PLACEBO_COMPARATOR | - |
| Treatment B | ACTIVE_COMPARATOR | Low dose ADS-5102 (amantadine extended release) |
| Treatment C | ACTIVE_COMPARATOR | A mid-dose ADS-5102 (amantadine extended release) |
| Treatment D | ACTIVE_COMPARATOR | High dose ADS-5102 (amantadine extended release) |
| Name | Type | Description |
|---|---|---|
| ADS-5102, 274 mg | DRUG | Oral capsules |
| ADS-5102, 137 mg | DRUG | Oral capsules |
| Placebo | OTHER | Oral capsules |
| ADS-5102 | DRUG | Oral capsules to be administered once nightly at bedtime, for 13 weeks. |
| ADS-5102 (extended release amantadine HCl) | DRUG | Oral capsules to be administered once daily at bedtime, for 8 weeks |
Inclusion Criteria: * Signed a current IRB-approved informed consent form * Successful completion of a prior double blind study of ADS-5102 in patients with MS walking impairment. Exclusion Criteria: * Based on the judgment of the investigator or Medical Monitor, participation in the study would ...
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|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 6 | PHASE3 | Frexalimab, Tolebrutinib, Teriflunomide |
| Bristol-Myers Squibb Company | BMY | 8 | PHASE3 | Ozanimod, BMS-986368, Zolacabtagene autoleucel |
| Novartis AG Sponsored ADR | NVS | 23 | PHASE3 | Remibrutinib, Fingolimod, Ofatumumab, Siponimod, Rapcabtagene autoleucel |
| Biogen Inc. | BIIB | 6 | PHASE3 | BIIB017, Interferon beta type 1a, Diroximel fumarate, Dimethyl fumarate, Interferon-beta |
| Zenas BioPharma, Inc. | ZBIO | 3 | PHASE3 | Orelabrutinib, Obexelimab |
| TG Therapeutics, Inc. | TGTX | 8 | PHASE3 | Ublituximab |
| Immunic, Inc. | IMUX | 3 | PHASE3 | IMU-838 |
| Amgen Inc. | AMGN | 1 | PHASE3 | ABP 692 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1195 |
| Kyverna Therapeutics, Inc. | KYTX | 3 | PHASE2 | KYV-101 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Ocrelizumab |
| Tiziana Life Sciences Ltd. | TLSA | 2 | PHASE2 | Foralumab |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD0120 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE1 | KITE-363 |
| Autolus Therapeutics Plc Sponsored ADR | AUTL | 1 | PHASE1 | obe-cel (AUTO1) |
ADS-5102 is an investigational extended-release formulation of amantadine HCl developed by Supernus Pharmaceuticals, Inc. (ticker: SUPN). It is a small molecule being studied in neurology for levodopa-induced dyskinesia in Parkinson's disease, and for walking impairment in multiple sclerosis. It is not yet approved and remains in clinical development.
ADS-5102 is being studied for levodopa-induced dyskinesia in Parkinson's disease and for walking impairment in multiple sclerosis. Both programs have reached Phase 3 testing, and the drug remains investigational rather than approved for any indication.
ADS-5102 is developed by Supernus Pharmaceuticals, Inc., which trades under the ticker SUPN. The company has sponsored the clinical program evaluating the extended-release amantadine HCl formulation in Parkinson's disease and multiple sclerosis.
ADS-5102 has completed Phase 3 clinical development. Four trials have been completed, including Phase 3 studies in multiple sclerosis walking impairment and in Parkinson's disease with levodopa-induced dyskinesia, plus one Phase 2 study. No trials are currently active, and the drug is investigational.
ADS-5102 has been evaluated in four completed trials: NCT03567057 and NCT03436199, Phase 3 studies in multiple sclerosis with walking impairment; NCT02471222, a Phase 2 study in the same population; and NCT02274766, a Phase 3 study in Parkinson's disease patients with levodopa-induced dyskinesia. All were randomized, double-blind, and placebo-controlled.
Yes. ADS-5102 is an extended-release formulation of amantadine HCl, and the names ADS-5102, 137 mg and ADS-5102, 274 mg refer to the same investigational product at different dose strengths. Searches for extended-release amantadine HCl in this development program refer to ADS-5102.