Revolutionary drug delivery technologies -- such as skin patches and inhalers -- accounted for nearly 40% of the total U.S. drug delivery market in 2001 (amounting to $5.2 billion), and are poised to take even more market share. According to a new study from Theta Reports, these technologies are growing in importance as pharmaceutical companies seek ways to extend patents on their blockbuster drugs and to deliver newer biotech-derived compounds by using new delivery technologies.. Although oral formulations still control over 60% of the market, such formulations are themselves evolving into different technological types, such as controlled release, delayed release, fast dissolving, and taste masked formulations. "Improved drug delivery offers pharmaceutical and biotechnology companies -- competing in the pharmaceutical industry -- a means of gaining a competitive advantage," said Anne Anscomb, author of the report. "Novel drug delivery technologies can accomplish this by improving the life cycle of existing drugs through advancements in safety, efficacy, and ease of use. New delivery technologies are also a key to the success of biotech/designer drugs. "Advances in biotechnology have facilitated the development of a new generation of biopharmaceutical products based on proteins, peptides, and nucleic acids. However, these compounds present drug delivery challenges because they are often large, complex molecules, or small molecules that degrade rapidly in the bloodstream. Thus, if improved functionality of proteins and peptide-based products is to be realized, the development of innovative and novel drug delivery technologies becomes a prerequisite." To this end, big pharma has been partnering with innovative firms specializing in delivery systems. Newer drug delivery technologies include: skin patches for pain treatment and hormone replacement, inhalation devices for asthma and osteoporosis, subcutaneous implants or implants within the body for contraception and cancer therapy, and needleless injections for vaccines, anesthesia, and diabetes.
US FDA puts deadline for Thyroid Drugs
The government has advised makers of some widely used thyroid drugs that they will have to begin cutting back distribution of any that haven''t won agency approval by Aug. 14. Among those affected could be the popular drug Synthroid. Abbott Laboratories, the drug''s maker, said it is filing a formal application for approval of the drug and sought to assure customers that the product will remain on the market pending approval. Synthroid is one of several thyroid-replacement drugs containing the chemical levothyroxine sodium that have been on the market for decades. The drugs are used by patients whose thyroid produces too few hormones. The Food and Drug Administration, which had never formally approved the drugs, announced in 1997 that manufacturers who wanted to continue selling them would have to file applications for approval. They agency said some of the products have a history of potency and stability problems. The deadline for approval was extended to Aug. 14 and two of the drugs have been approved:.With two approved products now available, the FDA announced Thursday that manufacturers of the drugs that have not yet filed a new drug application should plan to stop distribution by the deadline. Makers who have filed an application, but not yet received approval, will be asked to begin gradually reducing distribution with the aim of phasing out their product in two years, the FDA said. Abbott issued a statement expressing confidence that its product will be When the agency first called on drug makers to file applications for thyroid drugs, Knoll Pharmaceutical, the maker of Synthroid, filed a petition seeking for the drug to be termed ``generally regarded as safe and effective,'''' citing some four decades of use. The FDA turned that down. Knoll was acquired by Abbott earlier this year.
Nasal Spray For Pre-Menstrual Syndrome
Women suffering from premenstrual syndrome may soon get instant relief from a mix of pheromones, the airborne chemical messengers best known for their role in animal mating behaviour. They''ll get the pheromones in a simple nasal spray. The spray''s makers claim it will free women from the irritability, depression and other symptoms of premenstrual syndrome (PMS) and the more severe premenstrual dysphoric disorder (PMDD). Early tests on 20 women show that the spray eased both mood disorders and physical symptoms like breast pain. . Many researchers think the condition is sparked by fluctuating hormones affecting brain activity. As a treatment doctors often prescribe mood-altering drugs such as Prozac, which works by elevating serotonin levels in the brain. Human pheromones are powerful mediators of sexual attraction, anxiety and hormone-related disorders, says David Berliner, one of the founders of Pherin Pharmaceuticals of Mountain View, California, the company developing the spray. For years, few researchers believed human pheromones existed, but over the past decade Berliner and others have shown that these chemicals, exuded from human skin, can induce calmness in the opposite sex. The chemicals are detected by a specialised organ in the nose, called the vomeronasal organ or VNO.To target premenstrual syndrome, Pherin has developed a pheromone-like compound or "vomeropherin" known as PH80. With each inhalation, PH80 binds to receptors in the VNO. Nerve cells then speed the message to the hypothalamus.. The hypothalamus is involved in both the central nervous system and the endocrine system, regulating sexual drive, anxiety, fear and appetite among other traits. . Pherin is now setting up full clinical trials of the spray. "It''s an intriguing and novel approach," says Bruce Kessel, a specialist in PMS at the University of Hawaii.
New Pill after 50 years For Safer Blood Clot Prevention
A new blood-thinning pill seems to work at least as well as the standard treatments for warding off blood clots, but kicks in more quickly and could be safer and easier to take, new research indicates. Scientists who were presented with the evidence at a medical conference this week in Paris said that the new drug, Exanta, could dramatically improve the quality of life of millions of people taking blood clot treatments. It would be the first anti-clotting pill of its type to emerge since warfarin, also known as Coumadin, was introduced more than 50 years ago. The research, presented at a meeting of the International Society of Thrombosis and Hemostasis, showed the drug prevented blood clots in the legs of people undergoing hip or knee surgery just as successfully as warfarin or similar injectable drugs, known as low molecular weight heparins. People undergoing such surgery have the highest risk of getting a potentially fatal clot The main gripes with warfarin are that its performance is influenced by food containing vitamin K and by other drugs and that it is difficult to get the right dose . For that reason, doctors often also use the injectable heparin, which takes effect immediately. Although low molecular weight heparins do not require blood thickness monitoring, they are injected into the belly, which can be inconvenient. They also increases the risk of osteoporosis. The new drug is not affected by food, and patients using it don''t require injections or regular monitoring of blood thickness. Exanta, made by AstraZeneca, intervenes in the blood clotting process at a later stage than Coumadin or heparin. The latest research consisted of two studies. One compared Exanta to Coumadin in 680 knee replacement patients in Canada and the United States. The other pitted the drug against low molecular weight heparins in 2,788 Europeans getting new hips or knees. Experts say Exanta could become available within a year.
Bush Unveils voluntary drug discount program for Seniors
President Bush unveiled an initiative to give seniors rapid access to lower-cost prescription drugs, announcing that voluntary Medicare-endorsed drug discount cards will be available later this year. "Present the card at a participating pharmacy, and you receive a substantial discount," Bush said. "The new drug discount plan combines the purchasing clout of millions of seniors to negotiate lower prices than under the current system." The plan needs no congressional action, because officials said that the Medicare program has the authority to undertake the initiative. According to the Bush administration, that means seniors will save anywhere in the range of 10% to 25% on the retail prices of prescription drugs. A senior would only pay a one-time enrollment fee of no more than $25, to receive discounts from one of the private-sector plans. Republican lawmakers who attended Bush''s Rose Garden announcement told reporters that the discount plan was a good first step toward addressing drug prices. The Senate Finance Committee is planning to act on a Medicare reform package later this month. Under the congressional framework, $300 billion is set aside over the next 10 years for a drug benefit and Medicare reforms..
Spermless Fertilization?
An experimental fertility technique may make it possible to fertilize a human egg without using sperm. Australian researchers say they have found a way to use half the genetic material from any part of the human body to fertilize an egg, The Associated Press reports. In the procedure, an adult cell is chemically stimulated to eject one of the two sets of chromosomes it contains. (Unlike other human cells, sperm and egg cells each contain only one set of chromosomes, which are combined at fertilization.) The treated cell is then joined with an egg. The researchers stress that the technique is a long way from practical application -- so far, it has only been used to fertilize mouse eggs in a laboratory, the AP says. But if experiments are successful, the technique might one day make it possible for men who cannot produce sperm to father children, the AP reports
First oral contraceptive with new class of progestin launched
Berlex Laboratories, recently announced that YASMIN (drospirenone and ethinyl estradiol), a new, low-dose, monophasic oral contraceptive containing the novel progestin drospirenone is now available to U.S. women in pharmacies nationwide. YASMIN is the first oral contraceptive in over 40 years to contain a new class of progestin.. Only six percent of women discontinued use due to side effects In clinical studies. YASMIN has been available in several European countries, including Germany, since November of 2000.
It contains 3 mg of the progestin drospirenone that influences the regulation of water levels and electrolyte balance in the body..
Two Genes Hold Cancer Prevention Clues - Scientists
Two genes could be the key to understanding how to protect the body from developing cancer, an American scientist said Dr. Carl Anderson of the Brookhaven National Laboratory in New York told a medical conference in Glasgow that the genes DNA-PK and p53 are essential components of the body''s repair system. ``The human genome is like a great castle. In healthy cells the castle stands strong but as cancer develops it quickly crumbles. DNA-PK and p53 are the crucial cornerstones that hold the castle up,'''' he said in a statement released in London. ``When they are intact we are safe, but when either goes wrong the castle starts to collapse,'''' he said. Cancer develops when something goes amiss in a normal cell and instead of self-destructing in a process called apoptosis, it divides and multiplies uncontrollably.
Do Painkillers Harm Kidneys?
Taking an over-the-counter painkiller now and then won''t harm your kidneys. That''s the finding of a study published in the Journal of the American Medical Association, which offers some reassurance that moderate use of over-the-counter medications such as paracetamol, aspirin and ibuprofen doesn''t increase the risk of kidney damage, the InteliHealth News Service reports. In the study, Harvard Medical School researchers looked at 11,000 men participating in the Physicians Health Study. The men were healthy when they entered the study. They were asked each year about their use of painkillers. The men also gave blood samples that researchers tested for creatinine, a substance that can indicate early kidney damage. The researchers found that men who reported taking 7,000 or more painkiller pills over the 14-year study had no greater chance of having elevated creatinine levels than men who rarely took painkillers. In fact, very few of the study participants developed kidney disease at all over the course of the study. However, the InteliHealth story quotes the researchers and other experts as saying more studies are needed on the issue of painkillers to see whether use of painkillers affects kidney function in people who already have kidney disease and in women, who the researchers say may consume more over-the- counter pain relievers than men. They point out that the study also did not take examine the effects of long-term use or high doses of over-the-counter painkillers on the kidneys.
Compiled from WWW by Dr. Venkat Appaji Padmanabhunie-mail : appajipv@hotmail.com