Anaphylm temperature and pH pharmacokinetic study

10 evidence topics · 1 source

Objective

Effect of oral cavity temperature and pH on absorption

“The single-dose, five-period, randomized crossover study was designed to compare the PK and pharmacodynamics (PD) of Anaphylm just after consuming normal water (hot, cold, and room temperature), lemon water, and baking soda water.” (opens the source at this quote in a new tab)

Location and study date

Topline results reported in June 2024

“06.25.24 at 8:00 AM EDT” (opens the source at this quote in a new tab)
“today released positive topline pharmacokinetic (PK) data from the temperature / pH study of its product candidate Anaphylm™ (epinephrine) Sublingual Film.” (opens the source at this quote in a new tab)

Study design

Single-dose five-period randomized crossover design

“The single-dose, five-period, randomized crossover study was designed to compare the PK and pharmacodynamics (PD) of Anaphylm just after consuming normal water (hot, cold, and room temperature), lemon water, and baking soda water.” (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 30 healthy adult subjects.” (opens the source at this quote in a new tab)

Treatment

Beverage conditions tested before dosing

“The single-dose, five-period, randomized crossover study was designed to compare the PK and pharmacodynamics (PD) of Anaphylm just after consuming normal water (hot, cold, and room temperature), lemon water, and baking soda water.” (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 and comparison to room temperature water

“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 30 healthy adult subjects.” (opens the source at this quote in a new tab)
“The table below provides the ratio of Cmax and AUC 0-60min following administration of Anaphylm under various test states when compared to room temperature water.” (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 30 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

Exposure ratios by test condition relative to room temperature water

Test condition	Cmax ratio to room temperature water	AUC 0-60min ratio to room temperature water
Cold water	“106%”	“98%”
Hot water	“104%”	“107%”
Lemon water (target pH: 3)	“98%”	“99%”
Baking soda water (target pH: 8)	“123%”	“132%”

Statistical interpretation of the exposure differences

“Topline PK data from the study showed no statistically significant difference in PK results based on changes in temperature and pH. The most consumed beverages, such as soda, milk, coffee, and juice, have acidity between lemon water and normal water. While not statistically significant, alkaline substances like baking soda showed a somewhat higher absorption level than room-temperature water.” (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 30 healthy adult volunteers and tested only water at three temperatures, lemon water and baking soda water, so it does not directly address the beverages and foods that the company noted fall between these acidity extremes. Pharmacodynamic results were not available at the time of the topline release, safety results were not reported, and only ratios relative to room temperature water were published, without absolute Cmax or area under the curve values or confidence intervals. No registry record or peer-reviewed publication of the study was located.