Samjin Pharmaceutical said on the 2nd it will introduce a new low-dose treatment to reduce the initial medication burden for patients with Alzheimer's dementia.
The product is "Newtoin tablet (donepezil hydrochloride) 3 mg." It is an additional strength following the existing 5 mg, 10 mg, and 23 mg, and was developed for use in titration therapy that starts at a low dose and increases step by step according to the patient's condition.
Donepezil-class dementia treatments often cause gastrointestinal side effects such as nausea and vomiting early in therapy, leading some patients to stop taking the drug. As a result, clinicians recommend titration therapy that begins with a low dose and gradually increases the dose.
According to Samjin Pharmaceutical, clinical research found that the group receiving 3 mg of donepezil had a lower incidence of initial adverse reactions than the 5 mg group. In particular, under recently revised National Health Insurance reimbursement criteria, underweight patients with a body mass index (BMI) below 18.5 kg/㎡ and patients age 85 or older who are sensitive to side effects can continue to be prescribed the 3 mg dose.
Accordingly, the inconvenience of having to split a 5 mg tablet in half, as before, is expected to decrease, and the company expects improvements in dispensing accuracy and medication convenience.
Samjin Pharmaceutical has expanded its dementia treatment lineup by introducing the standard-dose Newtoin tablets 5 mg and 10 mg, a 23 mg product for moderate to severe patients, and an orally disintegrating film (ODF) formulation that can be taken without water.
President Kim Sang-jin of Samjin Pharmaceutical said, "We have worked to reflect the needs of clinical practice to improve a patient-centered treatment environment and medication convenience," and added, "We expect Newtoin 3 mg to serve as a treatment option tailored to each patient's characteristics and help improve quality of life."
Meanwhile, Samjin Pharmaceutical was selected in April this year for the World Class Plus Project support program led by the Ministry of Trade, Industry and Energy. The company plans to use this as a springboard to expand indications for its new drug candidate SJN314, build an Antibody-Drug Conjugate (ADC) platform, and advance a next-generation controlled-release formulation platform, while pushing to expand its global business.