Bucks County firm gets FDA approval for low-dose weight-reduction medicine
A low-dose version of a weight-loss medicine that's been around more than 50 years has been approved by the Food and Drug Administration to be manufactured and sold by a Bucks County generic-drug maker.
KVK Tech in Newtown said Lomaira, a low-dose version of phentermine hydrochloride, in 8-milligram tablets, was shipped to pharmaceutical wholesalers Wednesday. The appetite depressant is typically prescribed in doses of 15 milligrams to 37.5 milligrams and is taken once in the morning before breakfast.
"The feedback we were getting from patients was they made it through breakfast and lunch, but were hungry again around dinnertime or late in the day," said KVK president and CEO Anthony Tabasso. "So we came up with Lomaira." The 8-milligram tablets can be taken up to three times a day, before meals.
"We also scored the tablet so the 8-milligram tablet can be broken in half," enabling doctors and patients to customize a weight-loss plan with the lowest effective dose, Tabasso said.
Privately held KVK Tech manufactures 25 FDA-approved medicines for pain management, obesity, and attention deficit disorder. Most are generic copies of brand-name medicines. All of the products are made in Bucks County. "Made in the USA is a hallmark of our manufacturing," the CEO said.
The low-dose medicine is intended for short-term use to aid in weight reduction in obese and overweight patients with body mass indexes of 30 or higher and 27 or higher, respectively, and at least one weight-related condition including high blood pressure and diabetes.
The first shipments of Lomaira were sent Wednesday to pharmaceutical wholesalers that will, in turn, supply pharmacies.
About two-thirds of Americans who take weight-loss prescription medications pay out of pocket because insurance companies won't cover the cost. "We heard from patients 'this is too expensive for us,'" Tabasso said.
The company has set up a low-cost "access" program that allows patients not enrolled in federally insured Medicaid or Medicare programs to pay no more than 50 cents a pill. Patients can sign up at www.Lomaira.com and receive a card printed from the website, entitling them to the discount at the pharmacy.
"We wanted to give patients this alternative," Tabasso said, "to make sure it stays affordable, and they never pay more than 50 cents a dose."
KVK Tech, founded in 2004 with five employees, has 250 today with plans to employ 400 by Jan. 1, 2018, he said.
Last year, the company bought Lockheed Martin's former 460,500-square-foot campus in Newtown, Bucks County. "We are in the design phase to repurpose the facility for pharmaceutical use," the CEO said.
In addition, KVK Tech is building a $50 million, 270,000-square-foot sterile-manufacturing facility in Langhorne near Sesame Place. The company plans to manufacture sterile injectable products, prefilled syringes and vials, and ophthalmic and other products. Construction is scheduled to wrap up by the end of the year.