# Naloxone Lotion for the Treatment of Pruritus in Mycosis Fungoides

> **NIH FDA R01** · ELORAC, INC. · 2021 · $173,100

## Abstract

7. Project Summary/Abstract
The project which is the subject of this grant application is a Phase 3 clinical study to demonstrate safety and
efficacy of Naloxone 0.5% Hydrochloride (HCl) Lotion for the relief of pruritus associated with [the] mycosis
fungoides (MF) [as well as Sèzary syndrome (SS), both being] form[s] of cutaneous t-cell lymphoma (CTCL).
The seriousness of pruritus (itch) that accompanies skin disorders such as MF, the most prevalent subtype of
CTCL, is often underestimated. Severe chronic pruritus has clinically significant effects on morbidity and
mortality that impact clinical management of the disease its costs. As a symptom, itch is uncomfortable and
annoying, distracts and disrupts activities of daily life, interferes with sleep, and may affect social interactive
behavior. Moreover, chronic pruritus has been associated with considerable impairment of quality of life
comparable to chronic pain.1 The mortality rate in patients with MF is estimated to be twice as frequent in patients
with itching than in those without itching.2 Current medications do not completely address the pruritus associated
with MF which leads to infections from excoriations. Naloxone 0.5% HCl Lotion will fill this unmet medical need.
Traditional anti-pruritic drugs, i.e. antihistamines, tricyclic antidepressants, and corticosteroids, are not generally
effective in managing the itch associated with MF.11 Current evidence suggests that MF related pruritus may be
mediated by a peripheral opinergic pathway and provides the scientific rationale for treating MF related pruritus
with the opioid antagonist. Naloxone is classified pharmacologically as an opioid antagonist with activity at
multiple opioid receptors including Mu, Delta, Kappa1 and Kappa3.3 The treatment of pruritus associated with
MF using a topical formulation of naloxone represents a novel therapeutic approach [as systemic administration
is not practical due to the short half life of naloxone in blood.]
This is a 6 – 9 week, double-blind, vehicle-controlled, crossover study of approximately 160 adult subjects that
have moderate to severe pruritus (a minimum score of 5 on the 0 – 10 point scale) associated with MF [or SS].
The study is composed of a 1 week non-treatment Screening Period during which subjects will be required to
complete a daily diary assessing overall pruritus. The 1 week Screening Period is followed by a two week
Treatment Period, 4 – 28 day Washout Period, and another two week Treatment Period. Subjects will be
randomized 1:1 to receive either Naloxone 0.5% HCl Lotion or Vehicle Lotion in the first Treatment Period, and
the other in the second Treatment Period. The primary efficacy variable will be the change from Baseline in the
weekly average of the 11-point Numeric Rating Scale (NRS) for Pruritus assessed at Day 14 of each Treatment
Period.
The planned duration of the Phase 3 study is approximately 2 years. Following this Phase 3 study, Elorac, Inc.
will conduct a 6 month sa...

## Key facts

- **NIH application ID:** 9999503
- **Project number:** 5R01FD005396-03
- **Recipient organization:** ELORAC, INC.
- **Principal Investigator:** Scott Phillips
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2021
- **Award amount:** $173,100
- **Award type:** 5
- **Project period:** 2016-09-05 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9999503

## Citation

> US National Institutes of Health, RePORTER application 9999503, Naloxone Lotion for the Treatment of Pruritus in Mycosis Fungoides (5R01FD005396-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9999503. Licensed CC0.

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