Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is indicated to dilate the pupil. Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10% is an alpha-1 adrenergic receptor agonist indicated to dilate the pupil (1 ). FDA label
Also known as Phenylephrine HCl Extended Release, SCH 002063, MK-9314
Phenylephrine · 6 trials · 8 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.
Preference was calculated based on total participants that completed the study. Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints: Which product, if any, did you prefer for the relief of nasal congestion? The possible answers were: * I preferred the relief of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet) * I preferred the relief of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet) or • I did not have a preference
Five hour (hr) range around the Tmax was defined as approximately 2 hours before to approximately 2 hours after the Tmax, including Tmax. The parameters will be compared between active drug and placebo using analysis of variance (ANOVA). The 95% 2-sided Confidence Interval (CI) on the difference between treatments will also be presented.
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 | - |
| Phenylephrine Hydrochloride Extended Release Tablets, 30 mg | EXPERIMENTAL | - |
| Phenylephrine Hydrochloride Immediate Release Tablets, 10 mg | ACTIVE_COMPARATOR | - |
| Phenylephrine HCl Extended-Release tablets 30 mg | EXPERIMENTAL | Phenylephrine HCl Extended Release tablets 30 mg |
| 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 Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg | DRUG | Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days. |
| Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg | DRUG | Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days. |
| Phenylephrine Hydrochloride (HCl) Extended-Release tablets 30 mg | DRUG | Phenylephrine HCl Extended-Release tablets 30 mg taken twice daily (12 hours apart) for 7 days. |
| 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 studied for nasal congestion, vasomotor rhinitis, and blood pressure effects. It is a small molecule developed by Bayer AG as an extended-release tablet formulation. The clinical program includes a Phase 3 consumer preference study in vasomotor and seasonal allergic rhinitis and a Phase 3 safety study comparing the 30 mg extended-release tablet with placebo.
Phenylephrine targets the alpha-1 adrenergic receptors ADRA1A, ADRA1B, and ADRA1D, where it acts as an agonist. By activating these receptors, phenylephrine is designed to produce vasoconstriction, which is the basis for its use in nasal congestion and its effects on blood pressure.
Phenylephrine extended-release tablets are developed by Bayer AG, which trades under the ticker BAYRY. Bayer conducted the clinical program for the 30 mg extended-release formulation, including the Phase 3 consumer preference study and the Phase 3 safety study versus placebo.
Phenylephrine extended-release tablets have reached Phase 3 clinical development. The program includes a completed Phase 3 consumer preference study and a completed Phase 3 safety study comparing the 30 mg extended-release tablet with placebo, along with a completed Phase 1 bioequivalence study.
Phenylephrine has been studied in NCT00976209, a Phase 3 consumer preference study of two phenylephrine hydrochloride formulations in 331 adults with vasomotor or seasonal allergic rhinitis, NCT00874120, a Phase 3 safety study of the 30 mg extended-release tablet versus placebo in 116 participants, and NCT01354418, a Phase 1 bioequivalence study in 24 healthy volunteers.
Yes. Phenylephrine, phenylephrine HCl extended release, phenylephrine hydrochloride (HCl) extended-release tablets 30 mg, and phenylephrine hydrochloride (HCl) extended release (ER) tablets 30 mg refer to the same product. These names describe the 30 mg extended-release tablet formulation of phenylephrine hydrochloride developed by Bayer AG.