Manzo Pharmaceuticals says the release of Lacto-Freedom could be an important healthcare breakthrough for millions of lactose intolerance sufferers worldwide
Following discussions between Manzo Pharmaceuticals and the US Food and Drug Administration, it has been determined that the company's lactose digestive aid, Lacto-Freedom, will not need FDA approval to be released to the public.
The FDA considers the probiotic to be a dietary supplement, and therefore outside the scope of the FDA approval process that would be required if the treatment were deemed to be a drug. This will greatly reduce the time to market for Lacto-Freedom and enable Manzo Pharmaceuticals to market the product to millions of people who suffer from lactose intolerance much sooner.
The company is taking the necessary steps to put a small human study in place and hopes to have it off the ground in a few months. The company feels the release of Lacto-Freedom could be an important healthcare breakthrough for millions of lactose intolerance sufferers worldwide.
'We are ecstatic about this determination because what would have taken years, can now be done in months,' said the company's CEO, Kenneth Manzo. 'The time and expense saved by this development is monumental for the company, and for the people who suffer from this life altering complication.'
He stated that the company is still going through with a smaller human trial to confirm that it is safe and works the way it is intended in humans, but the time and expense of this test does not compare to the strict testing and approval process needed when FDA approval is required.