Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Phenylephrine · 4 trials · 5 indications
* 4 = Very Acceptable * 3 = Acceptable * 2 = Somewhat acceptable * 1 = Somewhat unacceptable * 0 = Very unacceptable
The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), and 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.
The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. Participants rated congestion on a 4-point scale of severity from 0 (best) to 3 (worst), with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. Baseline was defined as the average of the daily scores over the 4 consecutive 24-hour periods before randomization.
| Arm | Type | Description |
|---|---|---|
| Phenylephrine HCl | EXPERIMENTAL | Subjects have a documented and/or self-reported history of allergic rhinitis with nasal congestion for at least 2 years. |
| Phenylephrine | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| PE 10 mg | EXPERIMENTAL | - |
| PE 20 mg | EXPERIMENTAL | - |
| PE 30 mg | EXPERIMENTAL | - |
| PE 40 mg | EXPERIMENTAL | - |
| Phenylephrine HCl Extended Release - Fasted | EXPERIMENTAL | Single dose phenylephrine HCl extended release tablet administered under fasted conditions on Day 1 in one of four study periods |
| Phenylephrine HCl Extended Release - Fed | EXPERIMENTAL | Single dose phenylephrine HCl extended release tablet administered after a high-fat, high-calorie breakfast on Day 1 in one of four study periods |
| Phenylephrine HCl Immediate Release - Fasted | ACTIVE_COMPARATOR | Three single doses of phenylephrine HCl immediate release tablet four hours apart, with the first dose administered under fasted conditions on Day 1 in one of four study periods |
| Phenylephrine HCl Immediate Release - Fed | ACTIVE_COMPARATOR | Three single doses of phenylephrine HCl immediate release tablet four hours apart, with the first dose administered after a high-fat, high-calorie breakfast on Day 1 in one of four study periods |
| Name | Type | Description |
|---|---|---|
| Phenylephrine HCl (Sinus Comfort, BAY112476) | DRUG | 30 mg Extended Release Tablets, single oral dose |
| Phenylephrine | DRUG | Phenylephrine hydrochloride 30-mg extended-release tablets, one tablet every 12 hours for 7 days |
| Placebo | DRUG | Placebo to phenylephrine hydrochloride 30-mg extended release tablets, one tablet every 12 hours for 7 days |
| Loratadine | DRUG | Loratadine, 10 mg, once daily as rescue medication, only if needed for intolerable allergic rhinitis symptoms |
| Phenylephrine HCl | DRUG | 10-mg immediate-release tablets, orally, up to 4 tablets per dose every 4 hours, for 7 days |
| Phenylephrine HCl Extended Release | DRUG | One phenylephrine HCl 30 mg extended release tablet orally |
| Phenylephrine HCl Immediate Release | DRUG | One phenylephrine HCl 10 mg immediate release tablet every 4 hours for three doses |
Inclusion Criteria: * Healthy male or female volunteers must be 18 to 60 years old. * Subjects must currently use or have previously used oral decongestant products. * Subjects must have a documented and/or self-reported history (of at least 2 years) of allergic rhinitis with nasal congestion. * Su...
Phenylephrine is used for nasal congestion due to allergic rhinitis, seasonal allergic rhinitis, and rhinitis. It is being developed by Bayer AG as an extended-release tablet formulation to relieve allergy-related nasal stuffiness in adults.
Phenylephrine is a small molecule that acts as a decongestant. It works by constricting blood vessels in the nasal passages, which reduces swelling and congestion. The specific molecular target is not disclosed in the available information.
Phenylephrine is being developed by Bayer AG, a pharmaceutical company traded on the OTC market under the ticker BAYRY. Bayer is conducting clinical trials to evaluate the extended-release tablet formulation for treating nasal congestion due to allergic rhinitis.
Phenylephrine is in Phase 3 clinical development for seasonal allergic rhinitis and nasal congestion due to allergic rhinitis. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed to assess its effects.
Phenylephrine has been studied in clinical trials including NCT01330017, NCT01413958, and NCT04534452. These trials evaluated its effects on nasal congestion in participants with seasonal allergic rhinitis and rhinitis, with enrollment ranging from 347 to 575 participants.
Phenylephrine is the active ingredient in phenylephrine hydrochloride, which is the salt form used in the extended-release tablets studied by Bayer. The clinical trials refer to phenylephrine hydrochloride extended-release tablets, indicating they are the same drug substance.