Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 1181

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 6
Chunk 1181
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 EM and iSFN and provide important insights about NaV1.7 as a potential target to
find novel pain medications as an alternative to opioids, the continuing primary standard of care in analgesics. We believe that
positive results from the Phase 2a study could not only act as support for CC8464’s potential in EM and iSFN but may also
provide guidance of its potential for other indications of peripheral neuropathic pain.

71 

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

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