Agomelatine offers renewed hope for depressed patients across the GCC
PROF. SIDNEY KENNEDY, Professor of Psychiatry at the University of Toronto, Canada and Prof.Dan Stein, Professor and Chair of the Dept. of Psychiatry and Mental Health at the University of Cape Town, South Africa, have presented new results, highlighting the powerful efficacy of Agomelatine in the treatment of anxiety amongst depressed patients when compared with other commonly prescribed antidepressants. The beneficial effects of Agomelatine were even more pronounced in the highly anxious depressed patients. Dr. Adel Karrani, Assistant Head of
Psychiatry at Rashid Hospital inDubai highlighted the significance of these results, explaining: “The drug trials indicate that depressed patients with anxiety will experience increased benefits from this medication. Agomelatine through its innovative mode of action targets the core symptoms of depression including anxiety. This is positive
associated with the traditional antidepressants, including sexual dysfunction, weight gain and sleeplessness. Agomelatine offers a promising alternative,” he explained. Another benefit to patients will undoubtedly be the fast onset of action. Agomelatine was found to significantly reduce anxiety scores as early as the second week of treatment; traditional antidepressants take between six to eight weeks to offer full benefits. Agomelatine is the first antidepressant
news for those currently suffering from the debilitating effects of anxiety.” Of the significance of this new drug to
the Dubai market,Dr. Karrani highlighted: “Approximately 10-15% of the population is diagnosed with depression, and I would estimate that we receive no fewer than 4,000 cases of anxiety and depression in our clinic at Rashid Hospital each year. “With a proven efficacy, Agomelatine doesn’t share the side effects commonly
that restores the circadian rhythms which is profoundly disturbed in depressed patients, therefore offering a totally innovative approach to depression treatment. Agomelatine is registered and available in
Europe since 2009 and has been registered by the Ministry of Health in Kuwait, Bahrain, Oman, Qatar and the UAE, and will soon be available for the treatment of adult patients suffering from MDD across the Gulf countries. ■
AH
Substitution of brand name with generic drug proves safe for transplant recipients
A NEW STUDY published in the American Journal of Transplantation reveals that substitution of a brand name immunosuppressive drug with a generic (manufactured by Sandoz) for preventing rejection of transplanted organs appears to be safe for transplant recipients. Tacrolimus is an immunosuppressive drug
that is used to prevent rejection of transplanted organs following organ transplantation. In August 2009, another pharmaceutical company received approval from the FDA for a generic tacrolimus product. In the first formal study of its kind,
Raman Venkataramanan, PhD, of the University of Pittsburgh, School of Pharmacy and School of Medicine, and researchers analyzed database information
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regarding tacrolimus concentrations and indices of liver and kidney function before and after generic substitution in 48 liver and 55 kidney transplant recipients. Substitution of brand name tacrolimus
product with the generic formulation resulted in an average reduction of 15.9% and 11.9% in concentration/dose ratio in clinically stable liver and kidney transplant patients, respectively. The substitution was safe, as no changes occurred in liver or kidney function and no acute rejection episodes occurred during the follow-up time period. An accompanying editorial by G.B.
Klintmalm of Baylor University Medical Center, while offering a different viewpoint, also calls upon the FDA to change the requirements for approval of these drugs in
order for the transplant community to trust and rely on generic immunosuppressive drugs for the treatment of transplant recipients. Klintmalm notes that “in order to safely
save healthcare dollars, it is urgent that the FDA step up to the plate to implement changes in its approval process for generics of critical-dose drugs.” ■
AH
NEWS
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