Enclosed is a copy of a letter I have just e-mailed to my MP, the Hon. Andy Mitchell...
Recent press disseminations indicate that the government of Canada is very near approving the use of marijuana for the relief of chronic pain. One of the most painful and debilitating sources of pain is osteoarthritis. I am not writing to pass judgment on the therapeutic use of marijuana but rather to express my dismay and utter frustration at the incredibly slow processes of the Therapeutic Products Programme, Health Canada.
You are likely not aware, but here in Canada, we have a company known as Dimethaid that has developed a medication called Pennsaid that effectively deals with severe AO pain without side effects. It has been extensively tested on thousands and monitored under the highest global standard for pain relief “WOMAC”.
In order to be as brief as possible, I included the company’s web address and several excerpts from recent press releases. I would appreciate it if you would inquire on my behalf as to Mr. Allan Rock’s feelings on the timeliness of the proposed legalization of marijuana and the ongoing delays of HBP approval for Pennsaid.
It seems clear to me that a grave disservice is being done to thousands of Canadians in need of chronic pain relief. Pennsaid works and works well. Please check it out…
dimethaid.com
Dimethaid to provide additional PENNSAID(R) clinical data to Health Canada
TORONTO, Aug. 28 /CNW/ - Dimethaid Research (TSE: DMX) announced today that the Therapeutic Products Programme, Health Canada, has discontinued its review of the New Drug Submission for PENNSAID(R), requesting additional clinical data. As part of Dimethaid's ongoing pre-marketing efforts, the required data is currently being analyzed and the Company does not foresee any difficulties in complying with this request and re-submitting for agency approval. The Canadian position differs from its British counterpart, which has conditionally approved PENNSAID(R) without requiring any additional data...
Dimethaid announces positive clinical results for PENNSAID(R)
NEW YORK, Oct. 2 /CNW/ - Dimethaid Research (TSE: DMX) announced today that the results from its latest clinical trial of PENNSAID(R) confirmed earlier findings of the drug's effectiveness. Discussion of the study will be included in the Company's presentation today at the UBS Warburg Global Life
Sciences Conference in New York City.
The Phase III double-blind, placebo-controlled, two-way parallel, clinical trial with PENNSAID(R) Topical Solution (1.5% diclofenac in a patented carrier solution) for osteoarthritis of the knee was conducted at multiple sites in Canada. The three primary outcome measures were the pain and physical function subscales of the WOMAC Osteoarthritis Index as well as a
patient global assessment with a secondary outcome measure being the stiffness subscale of WOMAC. Statistical analysis demonstrated that PENNSAID(R) provided significantly superior improvement (p less than 0.05) for all three primary
variables and the secondary variable, when compared to a control solution (the carrier without diclofenac). The 194 patients in this study included those with moderate to extreme pain. No drug-related serious adverse events were reported during the 6-week study.
"We are delighted with these findings," said Rebecca Keeler, President and CEO of Dimethaid Research. "The robust results of this study constitute strong confirmatory support for previous safety and efficacy studies on PENNSAID(R). These additional findings will be included in the New Drug Submission to Health Canada which we anticipate making in the near future."…
PENNSAID(R) has already been conditionally approved in the United Kingdom and the Company anticipates meeting all necessary conditions to obtain final approval with application to other member countries of the EU to follow thereafter…
Dimethaid files new drug submission for PENNSAID(R): Seeks marketing approval in Canada
TORONTO, Oct. 16 /CNW/ - Dimethaid Research (TSE: DMX) announced today that it has filed a New Drug Submission with the Therapeutic Products Programme of Health Canada, seeking marketing approval for PENNSAID(R), the Company's treatment for osteoarthritis.
"We are pleased to have been able to make our submission so quickly after completing our most recent clinical trial of PENNSAID(R)," said Rebecca Keeler, President and CEO of Dimethaid. "The submission contains very convincing data that demonstrates the effectiveness and safety of PENNSAID(R).
We will work closely with officials at the agency while they conduct their review and we look forward to being able to provide the first North American topical treatment for Canadians suffering from this disease."
The Company announced results earlier this month from a Phase III trial of PENNSAID(R). The robust results showed a clear benefit with PENNSAID(R), when compared to a placebo, for three primary variables (pain, physical function and a patient global assessment) and one secondary variable (stiffness). PENNSAID(R) has never been associated with any serious drug-related adverse events in its clinical trials, including a large study of close to 4000 patients lasting nearly 5 years. In contrast, oral medications treating osteoarthritis are often associated with many serious drug-related adverse events that can lead to hospitalization and in some cases, death.
Dimethaid receives final marketing approval for PENNSAID(R) Lotion in United Kingdom … Opens Door To Additional EU Markets
TORONTO, Nov. 27 /CNW/ - Dimethaid Research Inc. (TSE: DMX) announced today that it has received final marketing approval from the UK Medicines Control Agency (MCA) for its lead product, PENNSAID(R) Lotion, for the treatment of the symptoms of osteoarthritis.
The Company is proceeding immediately to seek approvals from other European Union (EU) countries. Under the Mutual Recognition procedure prevailing in the EU, the UK will act as agent for the rest of the EU Member States, whereby they can "mutually recognize" this approval and issue their own authorizations. Member countries include Germany, France and Italy, three of the largest pharmaceutical markets in the world.
"This first approval of PENNSAID in an important market is a significant milestone for Dimethaid," said Rebecca Keeler, President and CEO. "There are approximately seven million osteoarthritis sufferers in the United Kingdom, and we are very pleased to be able to offer them a safe and effective alternative to currently marketed non-steroidal anti-inflammatory drugs (NSAIDs)…
From the above press excerpts I hope I have been able to convince you that HPB is sitting on a medical treasure of monumental proportions. More people die from the treatment of
osteoarthritis than the disease ever kills. Existing treatments have catastrophic side effects resulting in untold hospitalization days and additional expenses. Why can this made in Canada company get it’s first approval in the UK, and expect subsequent approvals in the remainder of the EU and the US before Canada? Does this make sense? In this instance, I don’t think marijuana is the best alternative. |
