Company: PTHS
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001753926-25-000790
Chunk: 73

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 2
Chunk 73
---
 of its potential for other indications of peripheral neuropathic pain.  

Channel
may further expand its pipeline with other internal or external compounds in the future, but all other internally discovered compounds
are pre-clinical.

26

Benuvia Spray Formulations: In addition to our NaV1.7 programs set forth above, on December 23, 2023, we entered into an
exclusive licensing agreement (the “Benuvia License Agreement”) with Benuvia for a sublingual formulation of a Diclofenac
spray for the treatment of acute pain, a Rizatriptan intranasal spray formulation and an Ondansetron sublingual spray formulation
(collectively, the “Spray Formulations”). The Spray Formulations diversify our pipeline of non-opioid pain treatment
therapies, while adding therapeutic options for related conditions. The sublingual formulation of a Diclofenac spray for the treatment
of acute pain (the “Diclofenac Spray Formulation”) is patented and has started clinical development in human volunteers.
Preliminary pharmacokinetics suggest that this formulation may have a faster onset of action than oral Diclofenac tablets. Diclofenac
is an NSAID that is also marketed under additional brand names including Voltaren and Cataflam in its pill form. A single Phase
1 trial of the Diclofenac Spray Formulation was completed in 24 healthy volunteers wherein a single dose of 50mg diclofenac-potassium
was compared to 25 mg of Diclofenac Spray Formulation. In this trial, the blood plasma concentrations of Diclofenac rose more
quickly with the Diclofenac Spray Formulation than with the diclofenac administered orally by approximately 15 minutes. This suggests
that the Diclofenac Spray Formulation may have a faster onset of analgesia; however, additional trials may be needed to confirm
this effect. Additionally, the initial pharmacokinetic study demonstrated that a 25mg dose of Diclofenac Spray Formulation resulted
in lower systemic exposure to Diclofenac than the oral dose of 50mg diclofenac-potassium which means that an additional Phase
I pharmacokinetic study exploring additional higher doses of the sublingual diclofenac spray will likely be necessary to determine
the appropriate dose.

Rizatriptan,
whose