The Food and Drug Administration (FDA) approved Moxidectin Tablets for the treatment of onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older. Moxidectin is an anthelmintic indicated for the treatment of onchocerciasis due to Onchocerca volvulus.
Patients aged 12 years and older are recommended to take 8 mg (four 2 mg tablets) as a single oral dose, with or without food.
The drug bagged the FDA approval after the safety of Moxidectin Tablets was evaluated in two randomized, double-blind, active-controlled studies (Trial 1 and Trial 2).In Trial 1, 978 patients received Moxidectin Tablets as a single oral dose of 8 mg and 494 patients received ivermectin as a single oral dose of approximately 150 mcg/kg. In Trial 2, 127 patients received Moxidectin Tablets as a single oral dose ranging from 2 mg (this is not an approved dose) to 8 mg (38 received the recommended 8 mg dose) and 45 patients received ivermectin as a single oral dose of approximately 150 mcg/kg.
Efficacy was assessed by skin microfilarial density (microfilariae/mg skin) from the mean of 4 skin snips per person per time point up to 18 months post-treatment.
Treatment with moxidectin was found to be significantly superior to ivermectin(the current standard of care) in suppressing the presence of the microfilariae in the skin.
The most common adverse reactions (incidence > 10%) were eosinophilia, pruritus, musculoskeletal pain, headache, lymphopenia, tachycardia, rash, abdominal pain, hypotension, pyrexia, leukocytosis, influenza-like illness, neutropenia, cough, lymph node pain, dizziness, diarrhea, hyponatremia and peripheral swelling.
The limitations of the drug are Moxidectin Tablets do not kill adult O. volvulus parasites and the safety and efficacy of repeat administration of Moxidectin Tablets in patients with O. volvulus have not been studied.
Moxidectin was developed through a partnership between the not-for-profit social enterprise Medicines Development for Global Health (MDGH) and the World Health Organisation Special Programme for Research and Training in Tropical Diseases (TDR). “Achieving FDA approval is a critically important milestone for moxidectin, but our work to bring this medicine to those who need it most continues in earnest,” said Mark Sullivan, Founder and Managing Director of MDGH.
Onchocerciasis, also known as river blindness, is a disease caused by infection with the parasitic worm Onchocerca volvulus. Symptoms include severe itching, bumps under the skin, and blindness. It is the second-most common cause of blindness due to infection, after trachoma.