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NEWTOWN, Pa. — KVK Tech Inc. plans to release Lomaira tablets, a short-term, low-dose prescription medicine for weight loss, by the end of this month.
KVK said Tuesday that Lomaira (phentermine hydrochloride 8-mg tablets CIV) gained approval from the Food and Drug Administration. The low-cost medication is indicated for use during a short time period (a few weeks) for weight reduction in adults with an initial body mass index (BMI) of 30 or more (obese), or 27 or more (overweight) with at least one weight-related condition such as controlled high blood pressure, diabetes or high cholesterol.
Taken with regular exercise and a reduced-calorie diet, Lomaira is the only strength of phentermine hydrochloride that can be taken up to three times a day before meals, according to KVK.
“With Lomaira, we’re giving physicians and patients access to a low-cost, low-dose version of a weight-reduction medicine, phentermine, that has been prescribed by physicians for over 50 years. Appropriate patients can take Lomaira up to three times a day, before meals — not just in the morning, as with the higher dose formulations of phentermine,” stated Anthony Tabasso, president and chief executive officer of KVK Tech.”We developed Lomaira with this dosing flexibility and affordability in mind.”
Phentermine hydrochloride, an appetite suppressant, is the most commonly prescribed drug for weight loss, KVK noted. Over 7 million prescriptions are written for phentermine annually. The drug is typically prescribed in doses of 15 mg to 37.5 mg and is taken before or within a few hours of breakfast. The usual adult dose of Lomaira is one tablet three times a day one-half hour before meals.
The butterfly-shaped tablet is scored to facilitate administering one half of the usual dosage for patients not requiring the full dose, enabling doctors and patients to customize a weight-loss treatment plan. Dosage should be individualized to obtain an adequate response with the lowest effective dose, KVK said.
Two-thirds of Americans pay out-of-pocket for their weight-loss prescription medications, KVK reported. Through the company’s Lomaira Lo-Cost Access Program, eligible patients pay no more than 50 cents per tablet for the duration of treatment.
