GEROPHARM introduces a new original drug Pineamin® to the market
In spring 2016 GEROPHARM is going to introduce a new drug product Pineamin® tothe market, which will open a new therapeutic area for the company – women's health and the management of menopausal transition.
Pineamin® - the original Russian prescription drug developed for the treatment of neurovegetative disorders in menopausal syndrome in women with contraindications to menopausal hormone therapy (MHT) or in case of its refusal. The drug is available in the form of lyophilisate used to prepare the solution for intramuscular injection in a dose of 10 mg.
Most drugs, used in menopausal syndrome, are synthetic hormone drugs. They are used as menopausal hormone therapy (MHT) to alleviate menopausal disorders. MHT is an effective method of menopausal symptoms treatment, however, it can be accompanied by some adverse effects. The main are these: thromboses, body weight gain, fluid retention and increase of breast tumor risk in women with genetic predisposition. Therefore, despite high efficiency of MHT, there is a considerable number of groups of patients for whom such therapy is unacceptable.
The trial in the framework of the state registration of the drug Pineamin® was carried out in accordance with the International Protocol of Good Clinical Practice (GCP) in three leading research centers of the Russian Federation, under the leadership of authoritative gynecologists of Russia. The clinical trials, which hadhigh evidentiary standards (double-blind placebo-controlled), have proved that Pineamin® is an effective alternative for relieving unpleasant symptoms of menopausal syndrome withoutemploying MHT.
Gynecology is a new field of expertise for GEROPHARM. The company is more widely known in such areas like endocrinology (segment of drugs for diabetes treatment), neuropsychiatry, ophthalmology. It is also one of the leaders in the production of active pharmaceutical ingredients manufactured on the basis of the technology of endocrine-enzymatic extraction. The active ingredient of the drug Pineamin® are the polypeptides of PPG (Polypeptides of the Pineal Gland) epiphysis, which entering the woman's body, normalize the neurohumoral function of hypothalamus and hypophysis, controlling menopausal syndrome mechanisms.
The production of the new drug will be carried out on a full cycle principle at GEROPHARM-Bio plant, which is included into GEROPHARM Group, in Obolensk.
GEROPHARM pays a great attention to the quality, efficiency and safety of the manufactured drugs. It also makes everything possible to ensure their highest application properties. Decisions made on the new drug packaging are supposed to ensure convenience, safety and control on the drug Pineamin® administration.
There are several types of signs on the package, visual and tactile – for patients with impaired vision. The color code is represented by light pink stripes on the package and plastic cover of the same color that is designed to control the process of opening a bottle. Tactile code is represented by convex dots (Braille script). All surfaces of the blister with bottles are rounded and have no keen edges. This technological feature allows to avoid finger cuts and pricks when removing bottles.
The protection against a counterfeit product has several levels: a tamper-evident packaging ensures a flap with a punched edge, a tamper-evident packaging is provided with a colored plastic flip-off cover type.
Pineamin® will be available for consumers in the second half of March in online drugstore "Apteka.ru" (covers all Russia). There a patient can choose the most convenient drugstore where this drug will be delivered.