Diarrhea related to a typical amyotrophic lateral sclerosis (ALS) treatment might be a significant barrier to adhering to the medication, according to studies by Napo Pharmaceuticals.
While the name of the ALS treatment was not revealed — the study described the “ALS drug” — riluzole (offered as Rilutek and generics Tiglutik, and Exservan) and edaravone (offered as Radicava and Radicava ORS) are the only 2 that are extensively available in the U.S.
Doctors, clients, and caretakers who were surveyed reported diarrhea as a significant problem with the medication and it affected clients’ lifestyle, causing terminating treatment in a lot of cases.
“The results of both surveys indicate that chronic diarrhea may be a substantial compliance issue of patients receiving the ALS drug, and that the severity of the diarrhea — and its impact on patient quality of life, dignity, and the ability of patients to remain on the drug — may be higher than previously understood,” Lisa Conte, president and CEO of Napo’s parent business Jaguar Health, said in a business news release.
Napo markets a treatment called crofelemer under the brand Mytesi for diarrhea in grownups with HIV/AIDS who are on anti-retroviral treatment. The business is examining crofelemer for other signs, consisting of ALS.
Impact of diarrhea
Napo carried out 2 study research studies, among 15 neurologists who treat ALS clients in the U.S. and another including 15 clients or caretakers, for more information about the problem of diarrhea with the illness.
Most neurologists (87%) said the intensity of diarrhea connected to the ALS medication was moderate or serious for their clients and 13% said their clients had actually been hospitalized or needed medical interventions for diarrhea while taking it.
This lined up with the client and caretaker study, where 93% reported diarrhea intensity as moderate or greater and 27% said it was serious. The require for hospitalization or medical intervention was reported by 40%.
About two-thirds of clients and caretakers reported experiencing diarrhea throughout their time on the ALS medication, with 20% stating the signs increased gradually.
These negative effects were related to substantial lifestyle effects, with 79% of medical professionals stating diarrhea had a moderate to serious impact on their clients’ lifestyle and 93% of clients and caretakers reporting moderate or higher life quality effects.
More than half of doctors said they’d stopped recommending the medication due to diarrhea and 40% said their clients had actually avoided dosages. Nearly half of participants in the patient/caregiver study said the treatment was stopped because of diarrhea. Less than half of the clients took medications for handling it.
“The data from the Napo-sponsored survey of individuals who are either ALS patients or caregivers of an ALS patient underscores the importance of real-world patient reported outcomes (PRO) data and the importance of managing side effects for critical diseases such as ALS,” Conte said.
Potential of crofelemer
Napo thinks crofelemer might help ALS clients. The treatment is a plant-based medication cleansed from red bark sap — referred to as “dragon’s blood” — from the Croton lechleri tree in the Amazon rain forest.
The business notes it has actually developed a sustainable harvesting program under reasonable trade practices that guarantee high quality, environmental stability, and assistance for native neighborhoods in the rain forest.
The particle prevents channels in the intestinal system that moderate the motion of chloride into and out of cells. It works to help stabilize the electrolyte and fluid balance in the gut to avoid diarrhea.
“We believe it is important to evaluate the potential of crofelemer’s novel mechanism of action to improve the quality of life of patients treated with the ALS drug and help prevent discontinuations and dose reductions of their disease modifying medications due to diarrhea,” Conte said.
While there’s no medical trial including ALS clients, a Phase 3 trial called OnTarget (NCT04538625) is examining crofelemer as a preventive treatment in adult cancer clients.
