Diabetes Meds on the Horizon
With diabetes diagnoses on the rise, pharmaceutical companies are hard at work to produce new medications to treat type 1 and type 2. A new report by the Pharmaceutical Research and Manufacturers of America lists a total of 183 diabetes medications in the pipeline, either going through clinical trials or awaiting approval by the Food and Drug Administration. Twenty-six treat type 1 diabetes, 133 treat type 2, and 34 are being developed for diabetes-related conditions or diabetes in general. (Some of the medications treat both types of diabetes and are counted in each category.)
All medications must go through rigorous testing—the process usually takes from 10 to 15 years—before they hit the market. After a developer conducts its own tests on laboratory animals, a drug will begin Phase I clinical trials. During this stage, the drug's safety is tested on 20 to 100 volunteers. The next stage, Phase II, tests the drug's effectiveness on 100 to 500 volunteers and looks for any side effects. The final stage before approval involves 1,000 to 5,000 volunteers and aims to prove the drug's effectiveness. During Phase III trials, researchers monitor patients for any bad reactions.
If a medication makes it through all three stages of clinical testing, it's sent to the FDA for review and approval. Most drugs don't make it this far—and still others don't get the necessary approval. Once a drug has been released to customers, a manufacturer must conduct additional testing, known as Phase IV trials.
Following is the lowdown on some in-the-works meds:
- A medication in the DPP-4 inhibitor class that helps the body lower too-high blood glucose levels in people with type 2 diabetes.
Stage of development: Completed Phase III; manufacturer Novartis Pharmaceuticals has submitted the drug, vildagliptin (Galvus), to the FDA for approval.
- A medication that alters the genes believed to cause insulin sensitivity in people with type 2 diabetes.
Stage of development: Currently known as MBX-102, Johnson & Johnson's drug is undergoing Phase II clinical trials.
- A once-daily, injectable medication for type 2 diabetes (in the same class as Byetta) that stimulates insulin's release only when glucose levels go too high. It also suppresses the appetite.
Stage of development: Completed Phase III; the drug, liraglutide, manufactured by Novo Nordisk, is currently under review by the FDA. The agency's advisory committee is determining whether thyroid tumors seen in studies on mice pose a threat to humans.
- A once-weekly version of the injectable type 2 medication exenatide (Byetta).
Stage of development: Completed Phase III; manufacturers Amylin Pharmaceuticals, Eli Lilly, and Alkermes have submitted the drug for review by the FDA.
- Four inhaled insulins for people with type 1.
Stage of development: Afresa has completed Phase III. An application has been submitted to the FDA by manufacturer MannKind Corp. A yet-unnamed product produced by MicroDose Therapeutx has wrapped up its Phase I clinical trial. Alveair (produced by Coremed Inc.) and an unnamed product made by Baxter are both in Phase I trials.
- Two insulin skin patches for people with type 1 or type 2 diabetes.
Stage of development: Altea Therapeutics' product, currently known as AT1391, is undergoing Phase I and II clinical trials for both types of diabetes. Another patch, created by Dermisonics, is in Phase I trials.
- Three insulin nasal sprays for people with type 1 or type 2 diabetes.
Stage of development: An unnamed spray developed by MDRNA Inc. and Nasulin, developed by CPEX Pharmaceuticals are both in Phase II trials. An exenatide nasal spray from Amylin Pharmaceuticals and MDRNA are in Phase II trials.
- Four oral insulin medications for people with type 1 or 2 diabetes.
Stage of development: An unnamed drug produced by Generex Biotechnology is in Phase III clinical trials. Emisphere Technologies is conducting Phase I and II trials on its to-be-named product. Intesulin (by Coremed) and VIAtab (by Biodel) are both in Phase I trials.
- A vaccine to prevent type 1 diabetes.
Stage of development: The vaccine, named Diamyd and produced by Diamyd Medical, is in Phase III trials.