Cassipa Approved for Opioid Dependence

In continuation of my update on buprenorphine and naloxone

                                           

Cassipa (buprenorphine and naloxone), a film designed to be placed under the tongue, has been approved to treat opioid dependence, the agency said in a news release.

Both buprenorphine and naloxone have been approved previously for this purpose.

"Opioid replacement therapy can be an important part of effective treatment," said FDA Commissioner Dr. Scott Gottlieb. "Opioid use disorder should be viewed similarly to any other chronic condition that is treated with medication."

The newly approved drug duo should be part of a complete treatment plan that includes counseling and psychosocial support to treat people with opioid use disorder. Cassipa may only be dispensed by approved prescribers, the agency said.

Side effects of the drugs include oral numbness, burning mouth, inflammation of the mouth's mucous membrane, headache, nausea, vomiting, excessive sweating and constipation.

Cassipa is produced by Teva Pharmaceuticals USA, based in New Jersey. Its parent company is located in Israel.

https://en.wikipedia.org/wiki/Buprenorphine

https://en.wikipedia.org/wiki/Naloxone

Coffee May Have Another Perk for Kidney Patients

In continuation of my update on coffee

The benefit remained "even after considering other important factors such as age, gender, race, smoking, other diseases and diet," according to one of the study's lead authors, Miguel Bigotte Vieira, of North Lisbon Hospital Center in Portugal.

In the study, Vieira's team tracked data on 4,863 U.S. chronic kidney disease patients monitored from 1999 to 2010.

Although the study couldn't prove cause-and-effect, it found that greater caffeine intake was tied to greater life expectancy for people with chronic kidney disease.

Compared to those who consumed very little caffeine per day, people with caffeine intake in the high range had about a 25 percent lower risk of death over an average follow-up of five years.

People who consumed the most caffeine tended to be white and male, with more education and higher incomes. They were also more likely to be current or former smokers and heavier drinkers than those who drank only small amounts of caffeine.

The findings were published Sept. 12 in Nephrology Dialysis Transplantation.

According to the researchers, chronic kidney disease affects 14 percent of American adults, leading to higher health care costs and a greater risk of death.

So, simply drinking more coffee or other caffeine-laden beverages "would represent a simple, clinically beneficial and inexpensive option, though this benefit should ideally be confirmed in a randomized clinical trial," Vieira said in a journal news release.

One U.S. endocrinologist who wasn't connected to the study said there could be physiologic reasons behind the benefit.

"Coffee has had a bad reputation, but this study showed that people who drink coffee did better," said Dr. Robert Courgi, of Southside Hospital in Bay Shore, N.Y."Perhaps it is because coffee may help the blood vessels function better through nitric oxide," he said. Nitric oxide is a key player in healthy blood vessel function.

Ref: https://medlineplus.gov/caffeine.html

FDA Finds Another Carcinogen in Certain Valsartan Heart Meds

In continuation of my updates on Valsartan

There's more bad news for Americans who took certain brands of the common blood pressure medication valsartan.

The U.S. Food and Drug Administration on Thursday warned that it has found a second impurity in three lots of Torrent Pharmaceuticals' valsartan drug products, which are used to treat both high blood pressure and heart failure.

The FDA first recalled valsartan medicines back in July, after the Chinese company that makes the drugs, Zhejiang Huahai Pharmaceuticals, found a contaminant called N-nitrosodimethylamine (NDMA) in several batches of its active ingredient, valsartan API.

NDMA is a suspected carcinogen. However, there was some reassurance earlier this week for people who had used the recalled Chinese-made product. A study involving more than 5,000 patients followed for nearly five years found those who took the recalled valsartan were not more likely to develop cancer in the short term. Long-term cancer risk remains unclear, however.

Now, in a news release issued Thursday, the FDA said Torrent's valsartan 160 milligram (mg) (lot BV47D001) and 320mg (lots BV48D001 and BV48D002) tablets are also tainted with N-Nitrosodiethylamine (NDEA). NDEA is also classified as a possible cancer-causing agent by the U.S. Environmental Protection Agency.

Contamination by both NDMA and NDEA could result from a specific sequence of manufacturing steps and chemical reactions, the FDA explained. After NDMA was detected, the agency immediately began retesting all valsartan products, including the already recalled drugs and others sold in the United States, the agency explained.

The FDA's testing shows that not all products made using Zhejiang Huahai Pharmaceuticals' valsartan API contain the potentially dangerous impurities.

"As we continue to investigate the root cause of the impurities found in products that contain valsartan, our scientists are testing these products to better understand these impurities and to ensure they're not present in other products," FDA Commissioner Dr. Scott Gottlieb said in the news release.

He said the FDA is also taking steps to prevent similar contaminations in the future, and providing the public with up-to-date information.

"We'll also continue to work with global regulatory agencies to learn as much as we can about how these impurities came about and how they may affect patients' health around the globe," Gottlieb added.

The agency has created a running list of affected products, and urges all patients taking a valsartan drug to check the list periodically to see if their medication is affected.

If you find that you are taking a drug that's included in the recall, talk to your doctor immediately, the FDA said. People using a recalled valsartan drug should not discontinue treatment until their doctor prescribes them an alternative medication, the agency said.

FDA Approves Xelpros (latanoprost ophthalmic emulsion) to Treat Open-angle Glaucoma or Ocular Hypertension

In continuation of my update on latanoprost

Sun Pharmaceutical Industries Ltd. and Sun Pharma Advanced Research Company Ltd. (SPARC) announced U.S. Food and Drug Administration (USFDA) approval for the New Drug Application (NDA) of Xelpros (latanoprost ophthalmic emulsion) 0.005% for the reduction of elevated intraocular pressure (IOP, or pressure inside the eye) in patients with open-angle glaucoma or ocular hypertension. This approval is from Sun Pharma’s Halol (Gujarat, India) facility.

Sun Pharma in-licensed Xelpros from SPARC in June 2015 and this approval will trigger a milestone payment to SPARC. SPARC is also eligible for milestone payments and royalties on commercialization of Xelpros in the US.

Xelpros is the first and only form of latanoprost that is not formulated with benzalkonium chloride (BAK), a preservative commonly used in topical ocular preparations. Xelpros is developed using SPARC’s proprietary Swollen Micelle Microemulsion (SMM) technology.

“As the only BAK-free version of latanoprost, Xelpros will be an important and alternative treatment option for individuals with open-angle glaucoma or ocular hypertension,” said Abhay Gandhi, CEO, North America, Sun Pharma. “This approval, coming less than one month following the approval of CEQUA™ (cyclosporine ophthalmic solution) 0.09%, reaffirms the strength of Sun Pharma’s fast-growing Ophthalmics division and its commitment to serving the needs of patients with ocular disorders.”

Anil Raghavan, CEO, SPARC said, “Approval of Xelpros by USFDA is a significant milestone for SPARC. It is also a validation of our SMM technology which helps to solubilize drugs that have limited or no solubility thus eliminating the need for benzalkonium chloride (BAK).”

In randomized, controlled clinical trials of patients with open-angle glaucoma or ocular hypertension with a mean baseline Intraocular pressure (IOP) of 23-26 mmHg, Xelpros lowered IOP by a mean of up to 6-8 mmHg.

Xelpros will be commercialized in the U.S. by Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceutical Industries Ltd.’s wholly owned subsidiary.