Greenwood Village, Colo., U.S.A. – Ampio Pharmaceuticals, a clinical stage biopharmaceutical company developing drugs for the treatment of inflammation, eye disease, kidney disease, CNS disease, metabolic disease and male sexual dysfunction have announced that a pre-IND meeting with the FDA’s ophthalmology division of the Center for Drug Evaluation and Research (CDER) took place on July 31 2012 seeking guidance for a clinical trial path for Optina. A summary of the meeting is as follows:

• The meeting followed a letter from the FDA providing guidance for the path of approval of Optina in the USA.
• The FDA agreed to Ampio’s proposed indication for Optina as a drug for the treatment of Diabetic Macular Edema (DME) in adults.
• The FDA agreed that the approval process through the 505(b)2 pathway is acceptable.
• The FDA raised no safety or CMC concerns.
• The FDA agreed that no additional non-clinical studies are necessary and that guidance for the dose and inclusion/exclusion criteria for this larger trial may be drawn from the recently completed successful Canadian trial.
• The proposed study, agreed by the FDA to be conducted by Ampio, will be based on similar end points as the intraocular injectable drug, Lucentis

Dr. Vaughan Clift, Ampio’s Chief Regulatory Officer, noted: “We are now able to launch a larger study using visual acuity rather than Optical Coherence Tomography (OCT) as the measure of efficacy and we are able to adjust the dosage to body mass index (BMI) to achieve the optimal benefit.

“We are pleased that the injectable drug Lucentis is likely to be approved and made available to the underserved DME patients. We believe Optina may provide additional advantages to these patients, as Optina is administered orally and is based on a very low dose of a previously approved drug, danazol. Extensive clinical experience with the drug has allowed the FDA to permit Ampio to use the 505(b)2 path for drug registration.

The 505(b)2 is a significantly shorter and less expensive path than those of new chemical entities. There is an obvious advantage to an oral drug vs. one that requires injection directly into the eye. Complications such as eye infection, increased intra ocular pressure (IOP) and local eye irritation reported in the Lucentis studies are NOT a concern for Optina.”

Michael Macaluso, Ampio’s CEO, reflected on the achievement of this latest milestone, “One year ago we selected three drugs from our extensive pipeline and set as our goal the advancement of each drug through carefully managed clinical paths into late stage pivotal trials that are within our means to finance, are relatively short in duration and in full compliance with FDA guidance.

These preparatory clinical trials took place in Europe (Zertane), Australia (Ampion) and Canada (Optina). With this latest meeting with the FDA, we have met our interim goal. We now have two drugs poised for pivotal trials (Zertane and Ampion) and Optina is approved for a 505 (b) 2 pathway in the USA.”

About the Canadian Clinical Trial

The Optina™ trial, conducted at St Michael Hospital in Canada, was a phase II, placebo-controlled, double-masked study to evaluate the efficacy and safety of a 12-week treatment with oral Optina™ in adult patients with Diabetic Macular Edema (DME).  Three Optina™ doses were studied and administered orally twice daily.

Patients were randomized into one of the three Optina™ arms, or placebo. The primary endpoint was change from baseline to week twelve of treatment in retinal thickness as measured by Optical Coherence Tomography (OCT). Secondary endpoints were 1) change from baseline to week twelve in retinal volume and 2) change from baseline to week twelve in Early Treatment. The study results indicate a clinically meaningful reduction in edema at the appropriate dosage and a parallel improvement in visual acuity.

About Optina ™

Ampio is developing Optina™, an orally administered low dose of danazol, for the treatment of diabetic macular edema (DME).  Ampio’s Chief Scientific Officer discovered an unexpected activity in his investigation of the mechanism of action of danazol: very low doses reversed inflammation induced increases in the permeability of blood vessels, thus reducing vascular leakage.

Dr. Bar-Or subsequently managed In Vitro studies that suggested this effect may reduce the vasogenic edema produced from multiple diseases, including diabetic macular edema which can impair vision and cause blindness (Diabetic Macula Edema, DME). The specific Optina dosages are proprietary and subject to multiple patent filings.

Danazol, a derivative of the synthetic steroid ethisterone, was approved by the FDA in the 1970s for endometriosis and, more recently, for other chronic indications, including hereditary angioedema.

About Diabetic Retinopathy & Diabetic Macular Edema

Diabetic retinopathy is damage to the retina of the eyes caused by complications of diabetes mellitus and resulting in loss of vision.  Macular edema of the eyes is often an early form of diabetic retinopathy that causes significant vision loss.  Almost all Type 1 diabetics and more than 60% of Type 2 diabetics develop retinopathy.

There is no effective daily drug treatment for diabetic retinopathy other than general measures, such as controlling blood sugar, hypertension, blood lipids, etc.  Due to the global diabetes epidemic, diabetic retinopathy is recognized as a high, unmet medical need that would benefit from having oral therapeutic options available.

About Ampio

Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for inflammation, eye disease, kidney disease, CNS disease, metabolic disease and male sexual dysfunction. The product pipeline includes new uses for previously approved drugs and new molecular entities (“NMEs”). By concentrating on development of new uses for previously approved drugs, approval timelines, costs and risk of clinical failure are reduced because these drugs have strong potential to be safe and effective while their shorter development times can significantly increase near term value.

A key strategy includes actively exploring partnership, licensing and other collaboration opportunities to maximize Ampio’s product development programs. For more information about Ampio, please visit our website, www.ampiopharma.com.
Image Courtesy of  Public Citizen

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As required by the 2009 law granting the U.S. Food and Drug Administration authority over tobacco products, the Institute of Medicine issued a report regarding the type of scientific evidence and research the FDA should require of tobacco companies seeking to make “modified risk” claims about tobacco products.

Modified risk products are defined in the law as “any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.” Given the industry’s long and deadly history of deception, the IOM calls for rigorous, comprehensive and independent scientific evidence before any tobacco company will be allowed to claim that any of its products are less dangerous than other products.

This report lays out a comprehensive scientific roadmap for the FDA to follow in reviewing applications for modified risk tobacco products. It demonstrates the need for rigorous science, conducted and evaluated independent of the tobacco industry, before the industry is allowed to market any modified risk products.

It underscores the importance of the FDA considering the broad public health impact of introducing such products and not just the impact on individual tobacco users. And it properly puts the burden on tobacco manufacturers to produce adequate scientific evidence before allowing them to claim that any tobacco product reduces the risk of disease.

The IOM report makes it clear that the FDA must set a high scientific bar for allowing such claims given the industry’s history of deception about its products and of falsifying science. Such a high bar is critical to preventing a repeat of the decades-long fraud in which tobacco companies marketed light and low-tar cigarettes as safer despite knowing from their own research that they were just as harmful as regular cigarettes. This deception discouraged smokers from quitting and encouraged others to start, with devastating results for public health.

Before allowing a modified risk claim, the law requires the FDA to determine based on the scientific evidence that the product “as it is actually used by consumers, will (A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and (B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.”

This requires the FDA to consider whether any reduction in harm to an individual tobacco user may be offset by marketing that encourages non-users, including kids, to start using tobacco or discourages current tobacco users from quitting.

To effectively carry out this analysis, the IOM report calls on the FDA to require a wide range of scientific evidence that includes not only evidence and studies about the product’s contents and health effects, but also evidence regarding whether the product will promote initiation and continuation of tobacco use and how its marketing will be perceived by consumers. These are all critical issues that the FDA must consider in order to effectively protect public health.

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Carson Liu, M.D., a leading bariatric surgeon in Los Angeles, has praised the announcement earlier today by the FDA that warned 1-800-GET-THIN centers on deceptive advertising. The warning follows the deaths of five patients who had Lap Band procedures at clinics affiliated with the 1-800-GET-THIN campaign in Southern California over the past two years, according to lawsuits, autopsy reports, and interviews conducted by the Los Angeles Times.

“These are five deaths that should have never happened,” said Dr. Liu, who prior to opening his own private practice, headed the bariatric department at UCLA Medical School. Since 1998, he has performed more 3,700 bariatric surgeries, including the Lap Band, and is authorized by the Lap Band’s manufacturer, Allergan, to teach other surgeons Lap Band surgical procedures.

The FDA warned that the 1-800-GET-THIN organization’s billboards and advertising inserts to promote the Lap-Band procedure fail to provide required risk information, including warnings, precautions, and possible side effects. ”It’s the wild, wild West out there when it comes to bariatric surgery,” said Dr. Liu. “My only regret with today’s FDA announcement is why it took two years to issue the warning.”

Liu says patients of his who have gone to the 1-800- GET-THIN clinics describe harrowing experiences that led them to believe that the clinics are actually scamming the insurance companies.

One woman used up all her insurance on unnecessary tests and procedures. Others reported that the clinics falsify the patients’ height and weight to get insurance approval, perform unnecessary tests, and even require patients to undergo unnecessary surgery prior to the Lap-Band procedure. One man said he was told he had to have his normal gallbladder removed prior to the Lap-Band procedure.  Women were told they need to have their normal uterus removed prior to surgery.

“This type of behavior on behalf of medical professionals is outrageous and inexcusable. Ultimately, however, patients must empower themselves and realize that a Lap Band procedure is surgery with all the risk and consequences associated with any surgery,” said Dr. Liu.

Dr. Liu advises that patients considering Lap Band surgery to look for a center that is officially recognized as a Surgical Review Corp Center of Excellence run through the American Society for Metabolic and Bariatric Surgery. The Public needs to be aware that this is a safe outpatient procedure, if in the right hands.

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