Distribution firms seek local clinical trials before FDA on ivermectin use for COVID-19 treatment

ABS-CBN News

Posted at Apr 10 2021 07:52 PM | Updated as of Apr 10 2021 11:00 PM

Distribution firms seek local clinical trials before FDA on ivermectin use for COVID-19 treatment 1
The anti-parasitic drug ivermectin, widely circulating on the internet as an alternative drug to address effects of the COVID-19 virus. ABS-CBN News/file

MANILA - Two distribution firms have expressed interest to the Food and Drug Administration (FDA) in conducting local clinical trials for the use of anti-parasitic drug ivermectin in treating COVID-19. 

In a statement, IP Biotech Inc. (IPB) and Ambica International, Inc. (Ambica), said "a number of physicians" in the country have already recommended ivermectin for COVID-19. 

IP Biotech is the same company that represents Sinovac in the country, which was also pushed for emergency use. 

"The antiparasitic [drug] has been used empirically for the treatment of outpatients and hospitalized patients with COVID-19 in Honduras and in other regions of the world," the statement read. 

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However, infectious diseases expert Dr. Edsel Salvana earlier said that the supposed effectivity of ivermectin in helping to ease the respiratory disease is not backed by data despite more people advocating for the drug. 

Salvana, a member of the technical advisory group that advises the Department of Health (DOH), also cautioned against using ivermectin, citing potential side effects.

This is the reason, IP Biotech chairman Enrique Gonzalez said in the statement, that the drug should undergo local clinical trials as the fight against the pandemic "requires a multifaceted approach." 

“Ivermectin cannot be used on a mass scale safely unless it is validated through clinical trials and proper FDA registration. This is to ensure the safety and efficacy of a product before being made accessible to people,” Gonzalez was quoted as saying. 

"IPB and Ambica seek to work closely with regulators and an independently run clinical trial to validate ivermectin
as a treatment for COVID19," he added. 

Ambica's vice president also noted of the drug's "potential" in treating patients with the coronavirus, subject to clinical trial validation and regulatory approval. 

Ivermectin recently made headlines this week after Anakalusugan Party-list Rep. Mike Defensor said he would distribute ivermectin to the sick and elderly in Quezon City, despite FDA warnings.

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According to the DOH, ivermectin products registered in the country are for veterinary use, and are only allowed for the treatment of internal and external parasites as well as prevention of heartworm disease.

Despite previous warnings by international health organizations, the FDA has granted an undisclosed hospital a compassionate use permit of ivermectin as COVID-19 treatment.

The World Health Organization has also warned against the use of ivermectin in patients with COVID-19 except for clinical trials because of inconclusive evidence.

Merck, an ivermectin manufacturer, has also said its analysis did not support the drug's safety and efficacy for COVID-19.