Thursday, April 5th, 2012 at 10:01 am
The EMA has been notified by Novartis Europharm of the latter’s decision to withdraw its applications for an extension of the therapeutic indication for Exelon and Prometax (rivastigmine), 4.6mg/24h and 9.5mg/24h transdermal patches.
In March 2011, Novartis submitted an application to extend the marketing approvals for the two transdermal patches to include a new indication for the symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’s disease. At the time of the withdrawal, the application was under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Exelon was first approved in the EU in May 1998, and its duplicate, Prometax, was approved in December 1998. The transdermal patches are currently intended for the symptomatic treatment of mild-to-moderately severe Alzheimer’s disease.
The company stated that it decided to withdraw the application after the CHMP indicated that in order to conclude a favourable approval additional data was required, which could not be generated within the time-frame allowed in the centralised procedure. Both medicines continue to be approved in the currently approved indications.
Article source: Espicom’s business publication Drug Delivery Insight, edited by Sophie Bracken.
Wednesday, January 11th, 2012 at 2:41 pm
Alexza employees face the chop in company bid to prop up Adasuve development
In an effort to save cash in the current economic downturn, Alexza Pharmaceuticals has made the difficult decision to appoint a financial advisor to assist in exploring strategic options for the company. These options could include a possible sale or disposition of one or more corporate assets, a strategic business combination, partnership or other transactions. In order to conserve cash needed to support operations, Alexza has provided to all of its employees a 60-day notice of layoffs under the California WARN Act. The company expects to significantly reduce its workforce as it continues the actions necessary to pursue FDA approval of Adasuve (Staccato loxapine) and continues its MAA work with the EMA.
Recently, the Psychopharmacologic Drugs Advisory Committee (PDAC) of the FDA voted to recommend that Adasuve be approved for use as a single dose in 24 hours in conjunction with the FDA recommended REMS, for the treatment of agitation in patients with schizophrenia or bipolar mania. The vote on this question was 9/8/1 (yes/no/abstain). The PDAC also concluded that the product had been shown to be effective (vote of 17/1/0; yes/no/abstain), and that the product would be acceptably safe for use as a single dose in 24 hours, when used in conjunction with the REMS proposed by the FDA (vote of 11/5/2; yes/no/abstain). The Adasuve NDA has a PDUFA goal date of 4th February 2012.
Adasuve is an anti-agitation product candidate that combines Alexza’s Staccato system with loxapine, an antipsychotic currently available in the US as an oral formulation for the management of schizophrenia. The Staccato system is a hand-held, single-dose inhaler that delivers a medication comparable with intravenous administration. In clinical studies, Adasuve has shown an onset of effect in ten minutes of dosing, which is the first time point measured in Phase III studies.
Article source; Kindly provided by Sophie Bracken, editor of Espicom’s business publication Drug Delivery Insight
Tuesday, December 13th, 2011 at 9:25 am
Welcome back to the Medical Technology Blog. Today’s post is taken for Espicom’s business publication Drug Delivery Insight, which is edited by Sophie Braacken, please read on…
Prosonix has presented new research showing that a combination of two inhaled respiratory drug molecules in a pre-determined ratio within Multi-component Particles (MCP) significantly improved co-localisation of the active drug components in the lung. The presentation was made by Prosonix’ Dipesh Parikh at the Drug Delivery to the Lungs 2011 (DDL2011) conference in Edinburgh, UK.
In the presentation, Prosonix describes how its Umax technology has enabled the development of one such example of MCP, which combines budesonide (BDS) and formoterol fumarate dihydrate (FFD) in a single particle, in a pre-determined ratio with “exquisite” control and consistency. The combination of BDS and FFD forms the basis of AstraZeneca’s multi-billion dollar respiratory drug product Symbicort. Combining multiple active drug components into a single particle using Umax® technology is shown, using Raman chemical imaging, to result in optimal co-association and co-localisation of the drug molecules at the correct sites in the lung and respiratory tract.
The concurrent delivery of inhaled corticosteroids (ICS) and long-acting B2-adrenergic bronchodilators (LABA) is a key treatment for asthma and chronic obstructive pulmonary disease (COPD) with mutual synergy of action cited as important for clinical performance. Previous analysis by Prosonix of currently marketed suspension-based MDI and DPI combination product formulations, which consist of individual drug components in a simple mixture, has shown limited co-localisation. Compared with these combination products, the improved co-localisation of MCPs to targeted parts of the lung is expected to achieve more pronounced synergy and additive efficacy on the key target cells directly from the solid state, improving outcomes and leading in turn to lower doses and improved safety and compliance.
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Friday, November 11th, 2011 at 10:48 am
The FDA has handed over an award of US$2 million…
…to support two regional ‘Centres of Excellence in Regulatory Science and Innovation’ (CERSI) in the US. The centres, which will be located at the University of Maryland and Georgetown University, will focus on strengthening science and training needed to modernise and improve the ways drugs and medical devices are reviewed and evaluated.
In August 2011, the agency released the strategic plan for “Advancing Regulatory Science at FDA”, the main focus of which was to accelerate delivery of new medical treatments to patients, improve paediatric health, protect against emerging infectious diseases and terrorism, enhance safety and health through informatics, protect the food supply, modernise safety testing and meet the challenges of regulation. More recently, in October, the agency announced a related initiative, “Driving Biomedical Innovation: Initiatives for Improving Products for Patients”. This plan focuses on “continuing dialogue with companies, innovators, patients and other stakeholders to identify barriers to progress and better define what steps need to be taken to overcome any obstacles to innovation”.
Working with FDA scientists, CERSI researchers will assist the FDA in driving innovation in medical product development as well as in advancing laboratory, population, behavioural and manufacturing sciences. The agency chose to pilot the CERSIs in Washington, DC, to allow for the greatest possible face-to-face collaboration and training with FDA staff.
Thanks to Sophie Bracken for this article, Sophie is editor of Espicom’s business publication Drug Delivery Insight.