ROSELAND, N.J. — Emisphere Technologies Inc. has announced the U.S. commercial availability of Eligen B12, described as the first once-daily oral prescription medical food tablet to normalize B12 levels without the need for an injection.

A full-scale retail pharmacy rollout is part of Eligen B12’s go-to-market plan.

Emisphere said Thursday that Eligen B12 is indicated for the dietary management of patients who have a medically diagnosed vitamin B12 deficiency, associated with a disease or condition that can’t be managed by a modification of the normal diet alone.

The company noted that Eligen B12 is the first product to market using its advanced Eligen Technology, which utilizes a carrier — salcaprozate sodium (SNAC) — to “chaperone” B12 through the gastric lining and directly into the bloodstream independent of intrinsic factor, a protein made in the stomach that normally facilitates B12 absorption.

In addition, the technology may have potential application across a range of diseases and conditions, including diabetes and womens health needs, Emisphere added. For example, Eligen Technology is being used to develop oral formulations of insulin and GLP-1 receptor agonists.

“The launch of Eligen B12 is a transformational event, not only for Emisphere and its many supporters who have helped us achieve this milestone but, more importantly, for the patients who have been waiting for an effective oral alternative to treat vitamin B12 deficiency,” stated Emisphere chief executive officer Alan Rubino. “Eligen B12, the first of multiple products in development that use Eligen Technology, fills a significant gap in the B12 treatment landscape, offering prescription strength B12 that is clinically proven to normalize B12 levels without the need for an injection. This type of practical innovation is the backbone of our commercial expansion, one that can address a number of existing unmet medical needs while having a meaningful impact on the lives of patients.”

Medical B12 deficiency is a serious medical problem that, if left untreated, can cause irreversible damage to nerve cells and other co-morbidities. It can occur with a range of conditions in which there is an impaired capacity to absorb vitamin B12, including pernicious anemia, Crohn’s diseases and celiac disease. Long-term use of proton pump inhibitors (PPIs), a commonly used treatment to reduce acid in the stomach, also can impair the body’s ability to absorb B12, Emisphere reported.

Eligen B12’s go-to-market strategy includes a national field-sales force, a full-scale retail pharmacy rollout, a targeted advertising and promotional campaign, and a sophisticated medical education component, the company said.