Diagnostic Protocols and Alternative Treatment Options for Male Hypogonadism
Presented at the 13th Clinical Applications for Age Management Medicine, November 2012, Las Vegas, NV Rethinking the Hypothalamic-Pituitary-Gonadal Axis Unde...

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Diagnostic Protocols and Alternative Treatment Options for Male Hypogonadism - Video

Hypogonadism ¦ Treatment and Symptoms
XXXXXX #9669; Hypogonadism treatment mdash; Finding the right information about Hypogonadism treatment symptoms, is crucial to managing Hypogonadism. Learn more abou...

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Hypogonadism ¦ Treatment and Symptoms - Video

Male hypogonadism Prof Ossama Fouda
Male hypogonadism Prof Ossama Fouda.

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Male hypogonadism Prof Ossama Fouda - Video

Group 6 Mafia Presents: Opioid-Induced Hypogonadism
Dr. Natty Light gets the exclusive with Jay-Z and Beyonce on their drug-therapy problems.

By: Taylor Howell

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Group 6 Mafia Presents: Opioid-Induced Hypogonadism - Video

A cloud of suspicion hangs ominously over the heads of athletes in the UFC, their accomplishments viewed by many through the lens of performance-enhancing drug usage.

The use of PEDs is believed to be widespread throughout professional and high-level amateur sports, but even clean athletes whose accomplishments are the result of their athletic ability, hard work and perseverance, are tainted by the mess.

Little is done to stop the usage in combat sports. Post-fight drug testing catches some users, but most experts say it nabs only those who don't understand how to mask their usage.

In fighting, there is no regularly scheduled regimen in which an athlete has to report his or her whereabouts to a testing agency in order to be randomly checked within 24 hours.

So, every time a fighter wins, there is plenty of suspicion that it involved artificial assistance. UFC middleweight contender Vitor Belfort is the latest to feel the backlash.

Since it was learned he's been on TRT, Belfort has scored several highlight-reel knockouts and become a legitimate title contender. He's been pressed about the issue so much that he suggested someone beat up the reporter asking about it, a thoughtless move for which he later apologized.

UFC light heavyweight Henderson, who has had an exemption to use testosterone replacement therapy since 2007, said he believes there is a heavy amount of PED usage in the fight game.

"I think there is a decent amount [of PED usage in MMA]," said Henderson, a member of the 1992 and 1996 US Olympic wrestling teams who will fight Rashad Evans in the main event of UFC 161 at the MTS Centre in Winnipeg on Saturday. "Just like at the top level of any sport, there is a decent amount of it. Guys look for that edge."

Henderson is one of a handful of fighters who have been given a therapeutic use exemption (TUE) to partake in testosterone replacement therapy (TRT). Henderson was diagnosed with hypogonadism, leading to his TUE

There are a number of causes of hypogonadism, or low testosterone, including previous steroid usage. Dr. Jonathan Gelber, an orthopedic surgeon who writes the Fight Medicine blog estimated that approximately 1 percent of the population between 18 and 40 who have not used anabolic steroids would be hypogonadal.

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Mixed Martial Arts - Henderson pushing for Olympic-style drug testing in MMA

A cloud of suspicion hangs ominously over the heads of athletes in the UFC, their accomplishments viewed by many through the lens of performance-enhancing drug usage.

The use of PEDs is believed to be widespread throughout professional and high-level amateur sports, but even clean athletes whose accomplishments are the result of their athletic ability, hard work and perseverance, are tainted by the mess.

Little is done to stop the usage in combat sports. Postfight drug testing catches some users, but most experts say it nabs only those who don't understand how to mask their usage.

In fighting, there is no regularly scheduled regimen in which an athlete has to report his or her whereabouts to a testing agency in order to be randomly checked within 24 hours.

So, every time a fighter wins, there is plenty of suspicion that it involved artificial assistance. UFC middleweight contender Vitor Belfort is the latest to feel the backlash. Dan Henderson dodges a punch thrown by Lyoto Machida. (USA Today)

Since it was learned he's been on TRT, Belfort has scored several highlight-reel knockouts and become a legitimate title contender. He's been pressed about the issue so much that he suggested someone beat up the reporter asking about it, a thoughtless move for which he later apologized.

UFC light heavyweight Dan Henderson, who has had an exemption to use testosterone replacement therapy since 2007, said he believes there is a heavy amount of PED usage in the fight game.

"I think there is a decent amount [of PED usage in MMA]," said Henderson, a member of the 1992 and 1996 U.S. Olympic wrestling teams who will fight Rashad Evans in the main event of UFC 161 at the MTS Centre in Winnipeg on Saturday. "Just like at the top level of any sport, there is a decent amount of it. Guys look for that edge."

Henderson is one of a handful of fighters who have been given a therapeutic use exemption (TUE) to partake in testosterone replacement therapy (TRT). Henderson was diagnosed with hypogonadism, leading to his TUE

There are a number of causes of hypogonadism, or low testosterone, including previous steroid usage. Dr. Jonathan Gelber, an orthopedic surgeon who writes the Fight Medicine blog estimated that approximately 1 percent of the population between 18 and 40 who have not used anabolic steroids would be hypogonadal.

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Legitimate TRT user Dan Henderson pushing for Olympic-style drug testing in MMA

The US Food and Drug Administration (:FDA) recently issued a complete response letter (CRL) for Endo Health Solutions (ENDP) new drug application on Aveed. The company is looking to get Aveed (a long-acting testosterone undecanoate injection) approved as a treatment for male hypogonadism.

The FDA declined to approve the new drug application for Aveed in the present form, as it is apprehensive about the risks and complications which may emanate after the injection of the drug. While issuing the CRL, the US regulatory body asked Endo to develop a medication guide. Specifically, the FDA asked Endo to ensure that the Risk Evaluation and Mitigation Strategy includes the guide in addition to Elements to Assure Safe Use to address the safety issue mentioned above.

However, the US regulatory body did not ask the company to conduct additional studies on Aveed. The requirement of additional trials would have pushed up its research and development costs. Endo intends to respond to the CRL by the end of the third quarter of 2013.

We note that the Aveed setback is not the first one for Endo this year. Last month, Endo suffered a blow with the FDA turning down its request to prevent the entry of generic versions of its painkiller, Opana ER. The decision by the FDA implies that the generic formulations of the original version of Opana ER will continue to be available in the market.

Endo expects the FDA decision to impact its 2013 guidance adversely. The company expects the adverse FDA ruling to reduce 2013 total net sales of Opana ER by up to $120 million. Moreover, Endos 2013 adjusted earnings per share outlook is expected to be hurt by approximately 55 cents following the FDA verdict.

While announcing its first-quarter 2013 results, Endo stated that it expects adjusted earnings per share for 2013 in the range of $4.40$4.70 per share and revenues of $2.80$2.95 billion. The Zacks Consensus Estimate for 2013 pegs earnings at $4.31 per share on revenues of $2.8 billion. Endo intends to throw more light on its 2013 guidance in the coming months.

Moreover, another painkiller at Endo, Lidoderm is expected to face generic competition later in the year from Actavis, Inc. (ACT). This will hamper sales of the drug significantly.

Endo currently carries a Zacks Rank #3 (Hold). Jazz Pharmaceuticals (JAZZ) and Santarus, Inc. (SNTS) appear to be more attractive with a Zacks Rank #1 (Strong Buy) each.

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Read the Full Research Report on SNTS

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CRL for Endo Health's Aveed

The US Food and Drug Administration (:FDA) recently issued a complete response letter (CRL) for Endo Health Solutions (ENDP) new drug application on Aveed. The company is looking to get Aveed (a long-acting testosterone undecanoate injection) approved as a treatment for male hypogonadism.

The FDA declined to approve the new drug application for Aveed in the present form, as it is apprehensive about the risks and complications which may emanate after the injection of the drug. While issuing the CRL, the US regulatory body asked Endo to develop a medication guide. Specifically, the FDA asked Endo to ensure that the Risk Evaluation and Mitigation Strategy includes the guide in addition to Elements to Assure Safe Use to address the safety issue mentioned above.

However, the US regulatory body did not ask the company to conduct additional studies on Aveed. The requirement of additional trials would have pushed up its research and development costs. Endo intends to respond to the CRL by the end of the third quarter of 2013.

We note that the Aveed setback is not the first one for Endo this year. Last month, Endo suffered a blow with the FDA turning down its request to prevent the entry of generic versions of its painkiller, Opana ER. The decision by the FDA implies that the generic formulations of the original version of Opana ER will continue to be available in the market.

Endo expects the FDA decision to impact its 2013 guidance adversely. The company expects the adverse FDA ruling to reduce 2013 total net sales of Opana ER by up to $120 million. Moreover, Endos 2013 adjusted earnings per share outlook is expected to be hurt by approximately 55 cents following the FDA verdict.

While announcing its first-quarter 2013 results, Endo stated that it expects adjusted earnings per share for 2013 in the range of $4.40$4.70 per share and revenues of $2.80$2.95 billion. The Zacks Consensus Estimate for 2013 pegs earnings at $4.31 per share on revenues of $2.8 billion. Endo intends to throw more light on its 2013 guidance in the coming months.

Moreover, another painkiller at Endo, Lidoderm is expected to face generic competition later in the year from Actavis, Inc. (ACT). This will hamper sales of the drug significantly.

Endo currently carries a Zacks Rank #3 (Hold). Jazz Pharmaceuticals (JAZZ) and Santarus, Inc. (SNTS) appear to be more attractive with a Zacks Rank #1 (Strong Buy) each.

Read the Full Research Report on ACT

Read the Full Research Report on SNTS

More here:

CRL for Endo Health's Aveed

BAUDETTE, Minn.--(BUSINESS WIRE)--

BioSante Pharmaceuticals, Inc. (BPAX) announced today that on June 20, 2013, it received a letter from NASDAQ informing BioSante that, since the merger with ANIP Acquisition Company d/b/a ANI Pharmaceuticals, Inc. (ANI) constituted a business combination resulting in a change of control under Listing Rule 5110(a), BioSante was required to meet the initial listing criteria for the NASDAQ Global Market. The letter continued that, since BioSante did not meet the minimum $4 bid price requirement for initial listings under Listing Rule 5405(a)(1), NASDAQ had determined to delist BioSantes securities, and that BioSante could appeal this determination.

As part of its preparations for the merger, BioSante anticipated the delisting letter and intends to appeal the determination and request a hearing before the NASDAQ Hearings Panel. This hearing request, if made within the required timeframe, would mean that BioSantes securities remain listed at least until the panel renders its decision.

In the meantime, to address the bid price deficiency, the Company intends to hold, as soon as practicable, a special meeting of its stockholders to approve a reverse split of its common stock, among other matters. The purpose would be to increase the per share market price for the common stock to a level greater than the minimum $4 bid price in order to regain compliance with the NASDAQ Listing Rules.

Important Additional Information for Stockholders

This communication in this press release does not constitute a solicitation of any vote or approval. In connection with the proposed reverse split, BioSante is filing with the SEC a proxy statement, the definitive version of which will be sent to the stockholders of BioSante. Stockholders are urged to read the proxy statement (including any amendments or supplements) and other documents filed with the SEC carefully in their entirety when they become available because they will contain important information about BioSante and the proposed reverse split.

Stockholders will be able to obtain free copies of the proxy statement (when available) and other documents filed with the SEC on the SECs web site at http://www.sec.gov. Free copies of the proxy statement (when available) and other documents filed with the SEC also can be obtained by directing a request to BioSante, Attention: Investor Relations, telephone: (218) 634-3500. In addition, stockholders may access copies of the documents filed with the SEC by BioSante on BioSantes website at http://www.biosantepharma.com.

BioSante and its directors and executive officers and other persons may be deemed to be participants in the solicitation of proxies in respect of the proposed reverse stock split. Information regarding BioSantes directors and executive officers is available in BioSantes joint proxy statement/prospectus filed with the SEC on May 8, 2013.

About BioSante and ANI

BioSante is an integrated specialty branded and generic pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals through its wholly-owned subsidiary, ANI. In two facilities with combined manufacturing, packaging and laboratory capacity totaling 173,000 square feet, ANI manufactures oral solid dose products, as well as liquids and topicals, including narcotics and those that must be manufactured in a fully contained environment due to their potency and/or toxicity. ANI also performs contract manufacturing for other pharmaceutical companies. Over the last two years ANI has launched three new products and has eleven products in development. ANIs targeted areas of product development include narcotics, anti-cancers and hormones (potent compounds), and extended release niche generic product opportunities. BioSantes other products include an FDA-approved testosterone gel for male hypogonadism, which is licensed to Teva Pharmaceuticals USA, Inc. For more information please visit our websites, http://www.biosantepharma.com and http://www.anipharmaceuticals.com.

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BioSante Pharmaceuticals Receives NASDAQ Delisting Determination Letter

MALVERN, Pa., May 30, 2013 /PRNewswire/ --Endo Pharmaceuticals Inc., a subsidiary of Endo Health Solutions Inc. (ENDP) announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for Endo's long-acting testosterone undecanoate injection, AVEED, for men diagnosed with hypogonadism.

The complete response letter did not include requests for the company to perform additional clinical studies. The FDA outlined the steps necessary to support approval of the NDA and updated the requirement for a Risk Evaluation and Mitigation Strategy (REMS). Specifically, the FDA has requested that the REMS include a Medication Guide as well as Elements to Assure Safe Use (ETASU) to mitigate the risks and severe complications related to post-injection reactions.

"We are encouraged by the feedback received from the FDA in the complete response and appreciate the clarity around the path forward for AVEED," said Ivan Gergel, executive vice president of research and development and chief scientific officer of Endo Health Solutions. "We plan to submit a complete response by the end of the third quarter of 2013. We look forward to making this treatment option available to appropriate male patients in the U.S. diagnosed with hypogonadism."

About Endo

Endo Health Solutions Inc. (Endo) is a U.S.-based diversified healthcare company that is redefining healthcare value by finding solutions for the unmet needs of patients along care pathways for pain management, pelvic health, urology, endocrinology and oncology. Through our operating companies: AMS, Endo Pharmaceuticals, HealthTronics and Qualitest, Endo is dedicated to improving care through a combination of branded products, generics, devices, technology and services that creates value for patients, providers and payers alike. Learn more at http://www.endo.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption "Risk Factors" in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in our Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

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Endo Pharmaceuticals Provides Regulatory Update On AVEEDâ„¢ (Testosterone Undecanoate) Injection