CENTRAL NERVOUS SYSTEM

The goal of Italfarmaco in this therapeutic area is to keep providing physicians with solutions for still unmet therapeutic requirements for diseases of the Central Nervous System. In this area, the research laboratories of Italfarmaco have demonstrated the ability to be innovative in pharmaceutical technologies aimed to simplify treatment regimens, and to improve tolerability and adherence.

• Zarelis: (Venlafaxine 37.5, 75, 150 and 225mg tablets) indicated in the treatment of major depressive episodes, prevention of recurrences of major depressive episodes, treatment of social anxiety disorder. The peculiar characteristics of Zarelis are the innovative formulation in osmotic sustained-release tablets and the possibility of administering the dose of 225 mg in a single tablet. This enables the simplification of treatment regimens and the reduction of total number of tables taken by the patient.

• Zaredrop: (venlafaxine 75mg/ml in oral solution) Zaredrop is the single SNRI in liquid formulation available on the market, providing physicians with another therapeutic tool useful in cases of impossibility (organic or psychological) of taking solid formulations. Thanks to its graduated measuring device, it is also possible to use Zaredrop to obtain intermediate doses.

• Dropaxin: (paroxetine hydrochloride – oral drops, 10 mg/ml solution) the first paroxetine hydrochloride available in oral drops; indicated in the treatment of major depressive episodes, obsessive-compulsive disorders, panic disorders both with and without agoraphobia, social anxiety disorder / social phobia, generalized anxiety disorder, post-traumatic stress disorder. Dropaxin combines the established efficacy of paroxetine with the flexible dosage schedules offered by the formulation in oral drops, particularly important at the start and end of therapy. Betadex technology, an Italfarmaco patent, also increases the stability of gastric acids and improves the absorption and bioavailability of this drug.

• soniDOR (www.sonidor.it) is a product containing natural components, reworked in a modified release trilayer tablets. soniDOR has been designed to promote relaxation and sleep in those people who do not yet have an established sleep disorder but who would like to have a support for occasional or mild situations.
  The innovative pharmaceutical formulation allows to modulate actions of the different components.
  Fact and figures: the Hawthorn (the first layer, "fast", released in 5 minutes) was selected for its influence on cardiovascular regularity and on blood pressure; Lavender (the second layer, "intermediate", released in 45 minutes) has been choose for its influence on stress and sleep; lastly the hop (third layer, "retard and prolonged", together with the final portion of lavender, delayed release after two hours) for its important action on the quality of sleep. Like all food supplements, soniDOR can be purchased, without medical prescription.

• Profeden Plus is a dietary food supplement formulated as a synbiotic, a combination of prebiotic fibers (Fructooligosaccharides) capable of producing beneficial effects on human health by selectively stimulating the growth and activity of useful bacteria, together with 7 different species of probiotic bacteria (live microorganisms) which if administered in adequate quantities confers a health benefit on the host.
  The prebiotic fibers together with the probiotic microorganisms contained in Profeden Plus, work in synergy to maintain or restore the balance of the beneficial intestinal flora.
  The intestinal flora can be altered by numerous factors (antibiotic therapies, unbalanced diets, intestinal disorders, physical or mental stress) establishing a dysbiosis, a condition often associated with various and important intestinal and extra-intestinal problems, such as metabolic and alvus disorders.
  Profeden Plus is available in packs of 10 sachets, each containing 990 mg of Fructo-oligosaccharides (FOS) and 7 different species of useful microorganisms normally present in the digestive system, including Lactobacillus rhamnosus GG, in quantities of 10 billion Colony Forming Units (CFU).
  Profeden Plus is available in all public pharmacies.

• Sonirem: (Zolpidem tartrate oral drops, 10 mg/ml solution) indicated in patients with insomnia. Sonirem minimizes addiction, tolerance and rebound insomnia, common side effects of Benzodiazepines often used in sleep disorders. This characteristic, very peculiar, has paved the way to the ‘selective’ hypnotic drug, assuring the sleep quality and protecting the conscious participation in diurnal activities. Sonirem for the first time enables to use a Z-drug (as these compounds are commonly called) in liquid oral formulation, drops, thus improving treatment adherence and therapeutic efficacy.

• Gliatilin: (Choline alfoscerate 400 mg capsules 1,000 mg/4ml solution for injection) cholinergic psychostimulant agent, activating the central nervous system of older patients, acts on cognitive and mnesic functions, as well as on the affective and behavioral areas impaired by involutional brain diseases. Unlike the other nootropic agents, Gliatilin acts by a dual mechanism, assuring a high amount of choline in brain and providing glycerophosphate to restore the phospholipid neuronal membranes.

Rare diseases

Italfarmaco holds the international patent and the exclusivity of the first and sole formulation of riluzole as oral suspension (TEGLUTIK), specifically indicated for the treatment of Amyotrophic Lateral Sclerosis (SLA), a severely disabling disease. The new formulation, resulting from the expertise of Italfarmaco in pharmaceutical technique, is especially useful in patients with swallowing disorders (disphagic disorders) or under enteral feeding, in which patient treatment adherence is often impaired by the worsening of the disease.

Italfarmaco has strengthened its presence in rare disease area in 2019, by launching the medicinal product VOTUBIA to Medical Specialists: (everolimus, 2 mg and 3 mg dispersible tablets for oral use) is a prescription medicine approved for the treatment of a brain tumour, the subependymal giant cell astrocytoma (SEGA) associated to the genetic disease called “Tuberous Sclerosis Complex (TSC)”. The treatment is indicated in adult and pediatric patients that require a therapeutic intervention but cannot be curatively resected.
VOTUBIA is also approved as add-on treatment in patients aged 2 years and older with seizures related to TSC that have not responded to other treatments. VOTUBIA is the first approved and reimbursed medicine available in Italy for the treatment of two of the most important disease manifestations of Tuberous Sclerosis. The medicine acts by selectively blocking an enzyme pathway called mTOR, which has increased its activity as a result of the gene mutation behind the disease. Tuberous Sclerosis is a rare disease and VOTUBIA has been designated an “orphan drug” on August 2010.