Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PTI-821 Manipulated · 1 trial · 1 indication
Peak effect for drug liking based on bipolar visual analog scale from 0-100 where 0 is most negative response, 50 is neutral, and 100 is most positive response.
| Arm | Type | Description |
|---|---|---|
| PTI-821 Manipulated | EXPERIMENTAL | oxycodone 40 mg capsule |
| Oxycodone | ACTIVE_COMPARATOR | Oxycodone 40 mg IR tablet crushed |
| OxyContin | ACTIVE_COMPARATOR | Oxycodone ER 40 mg tablet crushed |
| Placebo | PLACEBO_COMPARATOR | Matching placebos for experimental and active comparator arms |
| PTI-821 Non-manipulated | EXPERIMENTAL | Oxycodone 40 mg non-manipulated |
| Name | Type | Description |
|---|---|---|
| PTI-821 capsule Manipulated | DRUG | PTI-821 (oxycodone) 40 mg extended release capsule |
| PTI-821 Non-manipulated | DRUG | PTI-821 (oxycodone) 40 mg capsule extended release capsule |
| OxyContin | DRUG | Crushed OxyContin (oxycodone) extended-release 40 mg tablet |
| Placebo | OTHER | Matching placebos for PTI-821 and oxycodone IR |
| Oxycodone | DRUG | Crushed oxycodone 40 mg immediate release tablet |
Inclusion Criteria:: * Healthy male and/or female subjects between the ages of 18 and 55 years, * Subject is a recreational opioid user who is NOT dependent on opioids * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and body weight \> 50 kg (110lbs). * Evidence of a personally signed and dated infor...
PTI-821 Manipulated is an investigational small molecule being studied for opioid abuse nondependent, a condition related to pain management. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated for its potential in this indication.
PTI-821 Manipulated is being developed by Cassava Sciences, Inc., a biopharmaceutical company. The company is conducting clinical research on this investigational drug for opioid abuse nondependent. Cassava Sciences is publicly traded under the ticker symbol FLNA.
PTI-821 Manipulated is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research for opioid abuse nondependent.
PTI-821 Manipulated has one completed Phase 1 clinical trial, NCT03475862, titled "Nasal Human Abuse Potential of PTI-821." The trial enrolled 38 participants in the United States, was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 18 years and older.
PTI-821 Manipulated is a form of the drug PTI-821, specifically manipulated for nasal administration in clinical trials. The trial NCT03475862 evaluated the nasal human abuse potential of PTI-821, indicating that the manipulated version is used for intranasal delivery in research settings.