Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-00345439 · 2 trials · 2 indications
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar visual analogue scale (VAS); where 0 mm = Not at all and 100 mm = Extremely.
High assesses the degree that a subject feels a good effect (ie euphoria) at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar scale); where 0 mm = Not at all and 100 mm = Extremely.
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar visual analogue scale (VAS); where 0 mm = Not at all and 100 mm = Extremely.
High assesses the degree that a subject feels a good effect (ie euphoria) at the time the question is being asked (that is, at the moment). It is scored using a 100 mm unipolar scale); where 0 mm = Not at all and 100 mm = Extremely.
| Arm | Type | Description |
|---|---|---|
| PF-00345439 (oxycodone) | EXPERIMENTAL | PF-00345439 (oxycodone) |
| Treatment A | PLACEBO_COMPARATOR | Placebo solution +placebo capsule + placebo capsule chewed. |
| Treatment B | EXPERIMENTAL | PF-00345439 taken whole + placebo solution + placebo chewed |
| Treatment C | EXPERIMENTAL | PF-00345439 chewed + placebo solution + placebo taken whole |
| Treatment D | ACTIVE_COMPARATOR | Oxycodone HCl immediate-release 40 mg tablets (eg, 2 x 5 mg + 1 x 30 mg) + placebo taken whole + placebo chewed |
| Name | Type | Description |
|---|---|---|
| PF-00345439 | DRUG | 5-80 mg twice-a-day for 12 months |
| Capsule | DRUG | Taken once |
| oxycodone | DRUG | 40 mg solution, taken once |
Inclusion Criteria: * Males and females who are ≥ 18 and ≤ 75 years of age with moderate to severe pain in one or more hip or knee joint(s) caused by osteoarthritis for at least three months prior to the Baseline Visit or persistent moderate to severe low back pain for at least six months while reg...
PF-00345439 is an investigational small molecule being developed by Filana Therapeutics, Inc. (ticker FLNA) for pain and for use in opioid users. It is in Phase 1 clinical development. It has been studied in placebo-controlled, randomized, double-blind trials, including a completed abuse potential study.
PF-00345439 is being developed for pain and for opioid users. Its clinical program includes a completed Phase 1 abuse potential study in opioid users and a completed long-term safety study in pain. It remains investigational and is not described as approved for any indication.
PF-00345439 is developed by Filana Therapeutics, Inc., which trades under the ticker FLNA. The company is the sponsor behind the drug's clinical program in pain and opioid users.
PF-00345439 is in Phase 1 clinical development. Its completed studies include a Phase 1 abuse potential trial and a long-term safety study in pain. The drug is investigational, and the available information does not describe it as FDA approved.
PF-00345439 has been studied in two completed trials: NCT01986283, a Phase 1 abuse potential study in opioid users with 67 participants in the United States, and NCT01559701, a long-term safety study in pain with 823 participants. Both were randomized, double-blind, and placebo-controlled.
PF-00345439 is also known as oxycodone. The name appears in the title of its long-term safety trial, NCT01559701, which is listed as a study of PF-00345439 (oxycodone). Searches for either name refer to the same investigational small molecule developed by Filana Therapeutics, Inc.