Advancing Nanoparticle Technology Creating Opportunities For Drug Developers - Examining Technology, Therapeutic And Market Factors

Advances in nanotechnology that enable drugs to be delivered in ways that preserve their efficacy and to precise therapeutic targets are creating a host of opportunities for drug developers. A variety of nanostructures are being investigated as functional drug carriers for a wide range of therapies, most notably cardiovascular medicine, autoimmune diseases, and cancer.

While the concept of nanoparticles in drug delivery is not new, the number of research programs and active drug development projects has escalated as funding to nanotechnology developers has increased. The result is the emergence of a host of novel nanotechnologies tailored to meet the physicochemical requirements of drug developers.

Nanoparticles have already improved the availability and efficacy of some drugs, but the capabilities that evolving technologies possess will leads to a dramatic increase in the number of therapies delivered via nanoparticles. In many cases drugs in nanocrystalline form can be administered in smaller doses because they can be delivered directly to the tissue and in controlled doses related to the patient's personal requirements.

These findings are contained in a new and comprehensive report: "Nanoparticle Drug Delivery: Technologies, Targets and Therapies." The survey concludes that nanoparticle-based drug delivery will gain traction at the expense of traditional drug formulation methods, particularly among emerging biologics.

More information is available at http://www.greystoneassociates.org.

About Greystone

Greystone Associates is a medical and healthcare technology consulting firm providing services in strategic planning, venture development, product commercialization, and technology and market assessment.

Medicare Claims To Be Used To Monitor Drugs For Post-Market Adverse Events

The Food and Drug Administration (FDA) recently launched an initiative to use information from Medicare Part D claims to investigate the performance of drugs on the market and rapidly identify potential adverse events.

The program, termed the Sentinel Initiative, will allow the FDA to detect post-market problems with drugs as they arise. In the past, the agency relied on voluntary reporting of safety concerns and sometimes had to wait years to find out how a drug affected the health of millions of patients.

ASHP supports FDA's efforts to improve drug safety, and the Society worked with Congress to achieve passage of the Prescription Drug User Fee Act in 2007, which includes provision that calls for the development of Risk Evaluation and Mitigation Strategies (REMS). The REMS approach attempts to identify drugs with known risks and ensure that they are dispensed safely.

The FDA will monitor the use of medications and other medical products by querying a new electronic system containing Medicare claims information. The FDA also plans to include medical records data from private entities such as healthcare organizations in the system.

In a related action, the Centers for Medicare & Medicaid Services (CMS) recently issued a final regulation that permits government agencies and academic researchers to use Part D claims data for public health and safety research and other projects. CMS says the personal information of Medicare beneficiaries is subject to strict privacy protections.

FDA urged to ban 8 food dyes

WASHINGTON (AP) -- A consumer advocacy group called on the Food and Drug Administration Tuesday to ban the use of eight artificial colorings in food because they have been linked to hyperactivity and behavior problems in children.

Controlled studies conducted over three decades have shown that children's behavior can be worsened by some artificial dyes, says the Center for Science in the Public Interest. The group noted the British government is successfully pressuring food manufacturers to switch to safer colorings.

Over the years, the FDA has consistently disputed the center's assertion. The agency's Web site contains a 2004 brochure that asks the question: "Do additives cause childhood hyperactivity?"

"No. Although this hypothesis was popularized in the 1970's, well-controlled studies conducted since then have produced no evidence that food additives cause hyperactivity or learning disabilities in children," the agency said.

Julie Zawisza, an FDA spokeswoman, said Tuesday that color additives undergo safety reviews prior to approval for marketing and that samples of each artificial coloring are tested. She said the agency reviewed one of the studies that the center cites in calling for a ban.

"(We) didn't find a reason to change our conclusions that the ingredients are safe for the general population," Zawisza said. "Also note that the European Food Safety Agency has a similar view as FDA's."

Dyes are used in countless foods and are sometimes used to simulate the color of fruits or vegetables. The additives are particularly prevalent in the cereals, candies, sodas, and snack foods pitched to children.

"The purpose of these chemicals is often to mask the absence of real food, to increase the appeal of a low-nutrition product to children, or both," said the center's executive director, Michael F. Jacobson. "Who can tell the parents of kids with behavioral problems that this is truly worth the risk?"

The center's petition asks the FDA to require a warning label on foods with artificial dyes while it mulls the group's request to ban the dyes outright.

Robert Brackett, chief science officer for the Grocery Manufacturers Association, said the overwhelming majority of scientific evidence confirms the safety of certified food dyes.

"Based on these findings, there is no need for consumers to alter their purchasing and eating habits," Brackett said. "They and their children can safely enjoy food products containing these food colors."

The colorings the center seeks to ban are: Yellow 5, Red 40, Blue 1, Blue 2, Green 3, Orange B, Red 3, and Yellow 6.

Review suggests asthma drugs safe, effective in COPD

By Megan Rauscher

NEW YORK (Reuters Health) - Previous research has linked a class of asthma drugs known as long-acting beta agonists to increased risk of adverse respiratory-related events or death in patients with COPD (chronic obstructive pulmonary disease).

However, a report published this month indicates this may not be the case.

The new report suggests that long-acting beta agonists have beneficial effects in patients with moderate-to-severe COPD and do not appear to increase the risk of respiratory deaths. Examples of long-acting beta agonists used to treat asthma and other respiratory conditions include Advair, Serevent, Foradil and Symbicort.

In the study, Dr. Gustavo J. Rodrigo, from Hospital Central de las Fuerzas Armadas, Montevideo, Uruguay and colleagues pooled data from 27 randomized clinical trials that compared two long-acting beta agonists with placebo or with two long-acting "anticholinergic" asthma drugs (for example, Spiriva) in patients with moderate to severe COPD.

Compared with placebo, long-acting beta agonist therapy reduced severe COPD flare-ups by 21 percent and did not increase death from COPD.

Treatment with a long-acting beta agonist had benefits "in terms of lung function, quality of life, and use of daily rescue medication" with short-acting beta agonists, Rodrigo noted in comments to Reuters Health.

However, in an editorial published with the study in the journal Chest, Dr. Malcolm R. Sears from McMaster University, Hamilton, Ontario, Canada, urges caution in applying this finding to the real world. "In COPD trials, patients are carefully selected and monitored, and asthma is generally excluded. In real life, asthma and COPD can be hard to disentangle especially in older patients," he writes.

Hence, accepting the current results that a long-acting beta agonist alone is appropriate and safe in patients with COPD "may put some patients who in fact have asthma at risk if treated in this manner," Sears warns.

Rodrigo's team also found that treatment with a long-acting beta agonist combined with an inhaled steroid was associated with lower respiratory death compared with a long-acting beta agonist alone.

"Given the reduced mortality with the use of inhaled corticosteroids in combination with long-acting beta-2 agonist therapy, one would argue that, in COPD, concomitant inhaled corticosteroid therapy is preferable to long-acting beta-2 agonist monotherapy," Rodrigo told Reuters Health.

The pooled data also showed that treatment with Spiriva decreased the incidence of severe COPD flare-ups compared with a long-acting beta agonist.

Commenting on this finding, Sears writes: "Overall, daily tiotropium (Spiriva) appears to be foundational as a long-acting bronchodilator in COPD, despite some equivocation on this matter in current COPD treatment guidelines."

PDE-5 Inhibition and HIV Risk: Current Concepts and Controversies

FDA, in collaboration with The University of Medicine and Dentistry of New Jersey, The National Institute of Mental Health, The National Institute on Drug Abuse, and The Centers for Disease Control and Prevention is announcing a consensus conference, PDE-5 Inhibition and HIV Risk: Current Concepts and Controversies. The objective of the conference is to bring together and review data related to the use of Phosphodiesterase type-5 inhibitors (PDE-5's) for the treatment of male erectile dysfunction, such as sildenafil, tadalafil, and vardenafil, and their relationship to HIV transmission in high risk men and their sexual partners.

The conference will address:

- PDE-5 use and sexual behavior among at-risk populations - PDE-5 use in combination with drugs of abuse - Risks and benefits of PDE-5 treatment in at-risk populations

Evidence-based guidelines will be developed for prevention, education and research on causes and consequences of high-risk sexual behavior.

The conference will take place September 26 and 27, 2005, at the Bolger Conference Center in Potomac, MD. Registration is required, and there is a registration fee for this conference (see link below).

PDE-5 INHIBITION IN HIV+ AND HIV- MEN: BIOMEDICAL, BEHAVIORAL AND SOCIETAL PERSPECTIVES

Phosphodiesterase type-5 inhibitors (PDE-5's) are highly effective and well-tolerated oral drugs for treatment of male erectile dysfunction (ED), a medical condition which affects about 180 million men, worldwide. Three specific drugs in this class (sildenafil, tadalafil, vardenafil) have been approved and are currently used by approximately 20-25 million men. Recent reports of potential use of these agents as "recreational drugs" by selected groups of men has raised concerns about a variety of health risks: primarily, the association of these drugs with high risk sexual risk behavior, as well as the increasing co-use with known drugs of abuse (e.g. crystal methamphetamines).

This conference will aim to bring together existing data on use of PDE5 inhibitors (with or without drugs of abuse) in men and women at risk sexually, or being treated for HIV, the potential impact on physical and mental health in users, and the possible threat of increased risk for HIV spread. A major goal of the proposed conference is to critically evaluate the available evidence of increased use of these drugs by high risk individuals, and their potential contribution to further high-risk sexual behavior in HIV+ or HIV- men. What are the epidemiological implications, if any, of these trends, and what steps should be taken in regard to prevention or education?

A related goal is to critically evaluate the state of knowledge regarding biobehavioral effects of PDE-5 inhibition on sexual behavior generally, and the potential pharmacological interactions with other prescription or non-prescription drugs. Both pharmacological and behavioral aspects of this association will be addressed.

A third major area of focus for the proposed conference will be on the treatment of sexual dysfunction in men with HIV/AIDS, and the potential risks and benefits of PDE-5 use in this group. Clinical management guidelines will be developed in this regard.

Finally, the conference will address legal, ethical and social policy aspects of PDE-5 use in high risk or HIV+ individuals. Potential initiatives for education and prevention, particularly those which involve collaboration of industry, academia and government will be explored.

Additional details and registration information can be found at http://ccoe.umdnj.edu/rwjms/PDE5/index.htm.

Richard Klein HIV/AIDS Program Director Office of Special Health Issues Food and Drug Administration

An archive of past list serve announcements is available on the FDA web site at http://www.fda.gov/oashi/aids/listserve/archive.html