Anaphylm self-administration pharmacokinetic study

11 evidence topics · 1 source

Objective

Comparison of participant self-administration with healthcare-provider administration

“The single-dose, three-period, randomized crossover study design compared the PK and pharmacodynamics (PD) of Anaphylm self-administered, Anaphylm HCP administered, and Adrenalin manual intramuscular (IM) injection HCP administered.” (opens the source at this quote in a new tab)

Location and study date

Topline results reported in July 2024

“07.25.24 at 8:00 AM EDT” (opens the source at this quote in a new tab)
“today released positive topline PK data from the self-administration study of Anaphylm™ (epinephrine) Sublingual Film.” (opens the source at this quote in a new tab)

Study design

Single-dose three-period randomized crossover design

“The single-dose, three-period, randomized crossover study design compared the PK and pharmacodynamics (PD) of Anaphylm self-administered, Anaphylm HCP administered, and Adrenalin manual intramuscular (IM) injection HCP administered.” (opens the source at this quote in a new tab)

Eligibility criteria

Healthy adult participants

“The primary PK parameters were the maximum amount of epinephrine measured in plasma (Cmax) and exposure, or the area under the curve (AUC), at various times after dosing in 36 healthy adult subjects.” (opens the source at this quote in a new tab)

Treatment

Three administration conditions

“The single-dose, three-period, randomized crossover study design compared the PK and pharmacodynamics (PD) of Anaphylm self-administered, Anaphylm HCP administered, and Adrenalin manual intramuscular (IM) injection HCP administered.” (opens the source at this quote in a new tab)

Study outcomes

Rationale for using maximum epinephrine concentration and area under the curve as the primary endpoints

Primary pharmacokinetic parameters

“The primary PK parameters were the maximum amount of epinephrine measured in plasma (Cmax) and exposure, or the area under the curve (AUC), at various times after dosing in 36 healthy adult subjects.” (opens the source at this quote in a new tab)

Baseline correction method for the reported concentrations

“Lines on the graph above represent the geometric means of baseline-corrected epinephrine concentration across study timepoints. Baseline-corrected values were calculated by subtracting from the mean of three pre-dose concentrations measured at 60-, 30- and 15-minutes prior to treatment administration.” (opens the source at this quote in a new tab)

Statistical analysis description

Number of participants (Planned and analyzed)

Participants dosed

“The primary PK parameters were the maximum amount of epinephrine measured in plasma (Cmax) and exposure, or the area under the curve (AUC), at various times after dosing in 36 healthy adult subjects.” (opens the source at this quote in a new tab)

Description of analysis sets

No evidence found.

Results

Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

Pharmacokinetic comparison of self-administration and provider administration

“There was no statistical difference between the Anaphylm self-administered and HCP-administered arms of the study. The median time to maximum concentration (Tmax) was 15 minutes for both the Anaphylm self-administered and HCP-administered arms, while the median Tmax for the Adrenalin IM HCP administered arm was 50 minutes post administration.” (opens the source at this quote in a new tab)

Primary endpoints met

“Meets primary study endpoints with pharmacokinetics (PK) comparable whether Anaphylm is administered by subjects or by healthcare providers (HCPs)” (opens the source at this quote in a new tab)

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

No evidence found.

Study limitations

Summary: study limitations

The study enrolled 36 healthy adult volunteers who self-administered the film under supervision in a clinical setting, which does not reproduce administration during an allergic reaction. The design was open label with an intramuscular comparator given by a healthcare provider, and only median Tmax values and a qualitative statement of no statistical difference between the self-administered and provider-administered arms have been released; Cmax, area under the curve values, confidence intervals, and safety results were not reported. No registry record or peer-reviewed publication of the study was located.