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Published on 09/10/07 at 10:47am

Critical Therapeutics starts Phase I trial of zileuton

Critical Therapeutics has initiated a phase I clinical trial to assess the safety and tolerability of an oral single dose of the R(+) isomer of experimental asthma treatment zileuton in healthy subjects.

Twelve subjects will be randomly assigned to one of two groups of R(+) isomer zileuton (100mg or 300mg). The trial is designed to confirm that the R(+) isomer of zileuton when dosed alone for the first time has the expected prolonged pharmacokinetic and potent pharmacodynamic profile.

R(+) zileuton combined in equal proportion with its mirror image isomer, S(-) zileuton, comprise racemic zileuton, which is the pharmaceutical ingredient in Zyflo (zileuton tablets) and Zyflo CR (zileuton) extended-release tablets.

Roger Rush, vice president, preclinical development, said: "We have generated preclinical data indicating that the R(+) isomer of zileuton could be a more potent leukotriene synthesis inhibitor with a more prolonged pharmacokinetic profile than the S(-) isomer. We believe these characteristics may allow for the development of the R(+) isomer as a next generation leukotriene synthesis inhibitor that offers a reduced dosing and/or a smaller tablet size compared with Zyflo CR.

"In addition to asthma, the successful development of the R(+) isomer may also allow for possible development opportunities in other diseases, such as chronic obstructive pulmonary disease, atherosclerosis and nasal polyps, in which the inhibition of the leukotriene pathway could provide benefit."

Related links:

Critical Therapeutics Inc: LSA company profile

Respiratory and Pulmonary System - Asthma Drug Pipeline Report

Stakeholder Opinions: Asthma Phenotypes  A changing paradigm

Commercial Insight: Asthma & COPD - Combination products still have blockbuster potential


Duramed launches oral oestrogen

Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals, has launched its marketing campaign for Enjuvia for the treatment of moderate-to-severe vaginal dryness and pain with intercourse: symptoms of vulvar and vaginal atrophy associated with menopause.

Enjuvia is claimed to be the first and only plant-derived oral oestrogen approved by FDA for the treatment of these specific symptoms associated with vaginal atrophy.

James Simon, clinical professor of obstetrics and gynaecology at George Washington University, said: "Enjuvia has been shown in clinical studies to provide relief of moderate to severe vaginal dryness and pain with intercourse: symptoms of vulvar and vaginal atrophy associated with menopause. Enjuvia's indication for the treatment of these moderate to severe vaginal symptoms associated with menopause affords women and healthcare professionals a new and effective treatment option for two of the most common symptoms associated with vaginal atrophy."

Related links:

Barr Pharmaceuticals Inc: LSA company profile

Stakeholder Opinions: Female Sexual Dysfunction - Results from Datamonitor's 2005 physician survey

Female Sexual Dysfunction: Prescription Drug Pipeline Overview 2007

Women's Health - Vaginal Infections Drug Pipeline Report


Lundbeck reports positive phase II results for depressive disorder drug

H Lundbeck has reported positive results from a newly unblinded, proof-of-concept clinical study with a compound for the treatment of major depressive disorder.

The clinical trial was a multicentre, double-blind, placebo-controlled trial including 426 patients with major depression. According to the company, Lu AA21004 showed highly significant improvements on the primary efficacy endpoints with both 5 and 10mg compared to placebo and had an attractive safety profile.

Anders Gersel Pedersen, head of development at H Lundbeck, said: "We are pleased that the encouraging results from this proof-of-concept study confirm our experimental expectations of Lu AA21004 as a potent and well-tolerated new drug for the treatment of major depression. Lu AA21004 is the most advanced project within the new bis-aryl-sulphanyl amine class of compounds for the treatment of mood disorders and anxiety, and we look forward to further exploiting the potential of these novel projects."

Lu AA21004 is jointly being developed by H Lundbeck and Takeda Pharmaceutical. Following analysis of the phase II data, H Lundbeck and Takeda will plan the next steps in the development of Lu AA21004.

Related links:

H Lundbeck AS: LSA company profile

Pipeline Insight: Depression - Novel drugs to grow third-line market

Commercial Insight: Depression -Atypical lifecycle management strategy rejuvenates depression market


Nastech Pharmaceutical starts Phase II obesity trial

Nastech Pharmaceutical has started a six-month, randomised, placebo-controlled dose ranging phase II study for evaluating its nasal spray in obese patients, with weight loss as the primary endpoint. The study will enrol approximately 500 obese patients.

The study will evaluate three different doses of PYY3-36 nasal spray compared to placebo and sibutramine (Meridia), a commercially available oral weight-loss drug. Patients in the active PYY treatment arms will take PYY3-36 nasal spray or nasal spray placebo three times daily prior to a meal over the 24-week period. The study design will enable patients to undergo an initial dose optimisation period to establish an optimal dose to continue over the duration of the trial.

The study will also evaluate other effects including comparing the proportion of patients who lose at least 5% or 10% of their baseline body weight as well as the effect on haemoglobin A1c (HbA1c) levels.

Steven Quay, chairman, president and CEO, said: "Nastech has developed a patient-friendly, non-invasive nasal spray dosage form of a naturally occurring peptide, PYY, which in the body signals the brain that you have consumed sufficient calories and to therefore stop eating. The phase II trial that we are initiating is designed to demonstrate the effectiveness of PYY nasal spray in promoting weight loss which, if successful in development and approval, could help treat what has become an international health epidemic affecting hundreds of millions of people worldwide."

Related links:

Nastech Pharmaceuticals Inc: LSA company profile

Metabolic Endocrinology - Obesity Drug Pipeline Report

Commercial and Pipeline Perspectives: Obesity - Lack of Reimbursement Limits Market Potential

Obesity Therapeutics: Understanding market dynamics (presentation)


European Commission grants orphan designation for liver cancer drug

Metabasis Therapeutics has been granted orphan medicinal product status for its novel HepDirect prodrug of cytarabine monophosphate for the treatment of hepatocellular carcinoma, or primary liver cancer, by the European Commission.

This designation is based on a recommendation from the Committee for Orphan Medicinal Products.

Dr Paul Laikind, president and CEO, said: "Patients with primary liver cancer often die within months of diagnosis and at this time, they face this disease without any approved drug therapy. This orphan medicinal product designation in the EU builds upon our previous success of obtaining orphan drug designation for MB07133 in the US. Both will help in the development of this product candidate and bring hope of a new treatment option to liver cancer patients in Europe and the US."

Dr Wayne Frost, vice president, regulatory affairs, said: "The granting of orphan medicinal product designation to MB07133 by the EC is an important piece of the global regulatory strategy for the development of this product candidate in the European Union. This designation provides protocol assistance in which the EMEA will provide advice on the development of MB07133, which should improve the chance of success at the time of marketing authorisation to commercialise this much needed therapy."

Related links:

Metabasis Therapeutics Inc: LSA company profile

Innovations in Cancer: Novel therapeutics, new diagnostics and future R&D strategies

Innovative and Targeted Cancer Therapies: Key technologies, new applications and leading players

Pipeline Insight: Cancer Overview - Increasing diversity offers both high risk and reward



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