Company: PTHS
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001753926-25-000503
Chunk: 562

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1C
Chunk 562
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 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 brand name is Maxalt, is used for the acute treatment of migraines as a pill. By a number of clinical measures it is thought
to be superior to Sumatriptan. Both Rizatriptan and Sumatriptan belong to a family of tryptamine-based medications named “triptans”
that work as serotonin 1A receptor (or 5-HT1A-receptor) agonists and are indicated for the treatment of migraine. An intranasal
spray formulation of Riz