DAN RESNIC - This is a radical new design concept, made of non-latex material and the first AI (anal intercourse) condom data ever presented to the FDA for review. The data will be used to help establish the first safety standards for a condom used exclusively for AI. ORIGAMI Condoms are designed foremost for the pleasure of both partners and simultaneously to improve safety. Its improved capacity for better sensation during AI is intended to increase consumer acceptability and to promote its consistent use among men and women currently at risk.
The non-latex material we developed is unique. It's been lab tested as a male condom against a leading brand of a male latex condoms. The ORIGAMI material had zero viral permability compared with the latex condom, which had 5% viral permeability. Viral permeability is tested by introducing virus smaller than HIV into sterile water inside the condom, suspended in sterile water for 72 hrs. The water outside the condom is then tested to detect virus that may permeate through the condom. The test is repeated in reverse, starting with virus outside the condom then testing for viral premeability in the opposite direction. The tests are repeated again with pinholes punctured into the condoms. Again, the ORIGAMI tested at zero viral permeability even with puncture holes while the latex condom failed. In addition, the new material will not degrade in sunlight as does a latex condom and, after accelerated aging tests, it is expected to offer an extended shelf life of 10-12 yrs.
Future condom studies currently under funding review include a new, reusable ORIGAMI elastomer material we developed that can be washed and dried in a washer/dryer at high temperatures and can even be sterilized in a microwave or boiling in water and air dried in sunlight without compromising its structural integrity. The latter could be especially significant in regions like Africa and India where cost and distribution can be issues that prevent consistent condom use.
Photos and further details will be made available following FDA pre-market approval.
I – Where is the research at the moment?
DR - Phase 1 research will begin next month, in July 2009, with the Behavioral Epidemiology Research Group at the UCLA Dept of Epidemiology, with co-Investigator Dr. Pamina Gorbach. R&D will be supported with the assistance of male and female consultants from design, medical and commercial sectors. The optimal design will undergo pre-clinical testing, with modified structural testing crietria appropriate for the higher stress in AI use. Clinical research will follow with study groups and data will be analized for final reports.
I – How are you collaborating with the NIH and UCLA? What is the timeline?
DR - As the PI for the project, I've awarded a sub-contract to UCLA, which will conduct the clinical research with volunteer couples who will test the condom in a unique study design developed by Dr. Gorbach, who heads the Behavioral Epidemiology Research Group at UCLA. The project has been funded by a substantial grant from the NIH. The study will run for 18-24 mos. starting July 1st. Subsequent Phase II research will take the project through to the end
of 2014, when the data can be reviewed by the FDA. Since there is no existing precedent the data cannot be reviewed under FDA's 510K application. Consequently, the process is much longer and much more expensive. The same is true of the ORIGAMI Female Condom we've developed. The FDA requires 3-4 similar products approved on the market before a similar device can be reviewed under a 510K application, which is typically a 90 day review process.
I – Why is it so important to have a condom specifically designed for anal intercourse?
DR- This is an excellent question. It would appear to many to be a frivolous and unnecessary product, however, the typical rolled condom design we are all familiar with, has not been tested for anal intercourse (AI), yet its the only means of protection available to men and women who engage in AI. The FDA states that condoms are the ". . . best available protection for anal sex..." although, to date, no data has been submitted to the FDA for review to support its use for AI.
I – Since unprotected anal intercourse is the most efficient means of sexual transmission of HIV, and since many people don’t use traditional condoms during anal intercourse each and every time, it seems odd that a condom like ORIGAMI hasn’t been thought of before. Why do you think that is?
DR- Inventive ideas for new condoms that address specific needs such as AI have been consistently inhibited by the high cost of R&D as well as the socio/political barriers that existed until 2008. It wasn't until the concept of a female condom emerged that it was even possible to consider an inseted anal condom. For many years people had tried using the female condom for AI but it's not strong enough and it's lacking the unique design features compatible with AI.
Essentially, condoms are tested and FDA approved for vaginal use only. The FDA is typically provided with testing documentation from condom manufacturers based exclusively on vaginal use, and consequently there are no established guidance documents available from the FDA for condoms used for AI. For many years, in the US and elsewhere, it was considered taboo to discuss AI. In recent years, the subject was discussed at a special summit conference conducted by the FDA, specifically intended to encourage manufacturers to produce condoms for AI, however, none of the manufacturers who attended the meeting followed through. No existing condom manufacturer would risk producing such testing data as the failure rate for breakage, leakage and viral permeability would be significantly higher than testing results for vaginal use.
The FDA relies on manufacturers to present data for their review. Unless a manufacturer submits data (of any medical device) for review, the FDA does not conduct independent testing. As a regulatory agency, they are authorized only to review data from manufacturers but the agency cannot conduct its own independent research to set guidelines. It would be cost prohibitive to cover all medical devices. FDA Guidance Documents are established over time based on existing products and related testing data provided by manufacturers. Regarding latex condoms, the most current guidance document for manufacturers was last updated with minor changes on November 14, 2005.
I – Next steps?
DR - We anticipate successful Phase I study data by June 2011, which we intend to follow with a larger, Phase II study. We will work closely with the FDA to help determine further testing criteria appropriate for condoms used for AI. For example, the breakage standards, not yet established for AI, will be significantly different from existing condoms designed and sold for vaginal intercourse. AI condoms must meet a higher safety standards than typical existing condoms that were originally designed in 1918 for vaginal sex.
Thank you Dan! We look forward to learning more about this important work.